Irrigation Catheter Suppliers
Limit companies to: Worldwide USA
Edwards Lifesciences Corporation | Address: One Edwards Way, Irvine, California 92614, USA 
www.edwards.com | Send Inquiry | Phone: +1-(949)-250-2500
FDA Registration: 2015691 Year Established: 1958 Annual Revenues: USD 1-5 Million Employee Count: ~5600 Quality: ISO 9001, CE Certified
Products: Annuloplasty Devices, Aortic Root Bioprostheses, Bioprosthetic Aortic Valves, Bioprosthetic Mitral Valves, Dopplers, Thrombectomy Devices, ...
Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics a more...
www.edwards.com | Send Inquiry | Phone: +1-(949)-250-2500
FDA Registration: 2015691 Year Established: 1958 Annual Revenues: USD 1-5 Million Employee Count: ~5600 Quality: ISO 9001, CE Certified
Products: Annuloplasty Devices, Aortic Root Bioprostheses, Bioprosthetic Aortic Valves, Bioprosthetic Mitral Valves, Dopplers, Thrombectomy Devices, ...
Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics a more...
Advanced Bionics Corporation | Address: 12740 San Fernando Road, Sylmar, California 91342, USA
www.advancedbionics.com | Send Inquiry | Phone: +1-(661)-362-1400
FDA Registration: 3006556115
Products: Magnetic Stimulators, Commercial Magnetic Stimulators, Bio-Magnetic Stimulators, Non-Invasive Magnetic Stimulators, Water Vooled Magnetic Stimulators, Hearing Aid Batteries and Accessories, ...
Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to more...
www.advancedbionics.com | Send Inquiry | Phone: +1-(661)-362-1400
FDA Registration: 3006556115
Products: Magnetic Stimulators, Commercial Magnetic Stimulators, Bio-Magnetic Stimulators, Non-Invasive Magnetic Stimulators, Water Vooled Magnetic Stimulators, Hearing Aid Batteries and Accessories, ...
Advanced Bionics Corporation focuses on the development of implantable, high-technology neuro stimulation devices. We concentrate in the manufacture of cochlear implant technology (restores hearing to more...
Bentec Medical,Inc. | Address: 1380 East Beamer St, P.O. Box 1553, Woodland, California 95776, USA
www.bentecmed.com | Send Inquiry | Phone: +001-(530)-406-3333
FDA Registration: 2939142
Products: Catheters, Drains with Reservoirs, Bags, Wraps & Tubing, Female Indwelling Catheters, Female External Catheters, Esophageal Catheters, ...
Bentec Medical, Inc. manufactures silo bags, drains, silicone sheeting, ventral wall defect silo bags, silicone elastomertubing, silicone blocks, catheter, and silicone T-tubes. Our Ventral Wall Defec more...
www.bentecmed.com | Send Inquiry | Phone: +001-(530)-406-3333
FDA Registration: 2939142
Products: Catheters, Drains with Reservoirs, Bags, Wraps & Tubing, Female Indwelling Catheters, Female External Catheters, Esophageal Catheters, ...
Bentec Medical, Inc. manufactures silo bags, drains, silicone sheeting, ventral wall defect silo bags, silicone elastomertubing, silicone blocks, catheter, and silicone T-tubes. Our Ventral Wall Defec more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
Hospira, Inc. | Address: 275 N. Field Dr., Lake Forest, Illinois 60045, USA
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in more...
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in more...
Hollister Incorporated | Address: 2000 Hollister Drive, Libertyville, Illinois 60048, USA
www.hollister.com | Phone: +1-(847)-680-1000
FDA Registration: 1480288 Year Established: 1921 Quality: ISO 9002, CE Certified
Products: Cotton & Rayon Dressings, Ostomy Drain Pouches, Ostomy Wafers, Medical Kits, Aseptic Wound Dressing, Neonatal Ostomy Pouches, ...
Hollister Incorporated delivers products for ostomy, wound care, incontinence & continence care, breastfeeding, patient identification, medical records, obstetrics and cold therapy. Our product Pouchk more...
www.hollister.com | Phone: +1-(847)-680-1000
FDA Registration: 1480288 Year Established: 1921 Quality: ISO 9002, CE Certified
Products: Cotton & Rayon Dressings, Ostomy Drain Pouches, Ostomy Wafers, Medical Kits, Aseptic Wound Dressing, Neonatal Ostomy Pouches, ...
Hollister Incorporated delivers products for ostomy, wound care, incontinence & continence care, breastfeeding, patient identification, medical records, obstetrics and cold therapy. Our product Pouchk more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Cook Group Incorporated | Address: P.O. Box 489, Bloomington, Indiana 47402-0489, USA
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
Biomet, Inc | Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
Stryker | Address: 2825 Airview Boulevard, Kalamazoo, Michigan 49002, USA
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
www.stryker.com/en-us/index.htm | Phone: +1-(269)-385-2600
Products: Saws (FDA Code: HSO), Titanium Plating Systems, Resorbable Plating Systems, Fracture Hardware, Cannulated Screws, Pelvic Plating Systems, ...
Stryker offers a full range of laparoscopic products that meet the performance needed by surgeons. From the uniform image created by our laparoscopes to our StrykeFlow II suction irrigation system, we more...
Jedmed Instrument Company | Address: 5416 JEDMED Court, St. Louis, Missouri 63129-2221, USA
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
Becton, Dickson & Co., | Address: One Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
Scientific Calibration Plus | Address: 2518 Reliance Ave, Apex, North Carolina 27539-6346, USA
www.scical-plus.com | Send Inquiry | Phone: +1-(919)-290-1124
Products: Stethoscopes, Electronic Stethoscopes (FDA Code: DQD), Single Head Stethoscope, Disposable Hypodermic Syringes, Disposable Irrigating Syringe, Medical Stethoscopes, ...
Scientific Calibration Plus provides surgical instruments, patient care products, pediatric supplies, endoscopic devices and gloves. Our cardiovascular products include electronic stethoscopes, single more...
www.scical-plus.com | Send Inquiry | Phone: +1-(919)-290-1124
Products: Stethoscopes, Electronic Stethoscopes (FDA Code: DQD), Single Head Stethoscope, Disposable Hypodermic Syringes, Disposable Irrigating Syringe, Medical Stethoscopes, ...
Scientific Calibration Plus provides surgical instruments, patient care products, pediatric supplies, endoscopic devices and gloves. Our cardiovascular products include electronic stethoscopes, single more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Applied Medical Technology, Inc. | Address: 15653 Neo Parkway, Cleveland, Ohio 44128, USA
www.appliedmedical.net | Send Inquiry | Phone: +1-(216)-475-5577, (800)-869-7382
FDA Registration: 1526012 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Self-Retaining Retractor Systems, General Medical Supplies, Non-Balloon Replacement Buttons & Accessories, Feeding Adapters, Single Port Right Angle Feeding Adapters, Decompression Tube, ...
Applied Medical Technology, Inc. develops and assembles medical devices. We offer innovative & reliable products for use in the medical and surgical environment, with a special emphasis on gastrostomy more...
www.appliedmedical.net | Send Inquiry | Phone: +1-(216)-475-5577, (800)-869-7382
FDA Registration: 1526012 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Self-Retaining Retractor Systems, General Medical Supplies, Non-Balloon Replacement Buttons & Accessories, Feeding Adapters, Single Port Right Angle Feeding Adapters, Decompression Tube, ...
Applied Medical Technology, Inc. develops and assembles medical devices. We offer innovative & reliable products for use in the medical and surgical environment, with a special emphasis on gastrostomy more...
B. Braun Medical Inc. | Address: 824 Twelfth Avenue, Bethlehem, Pennsylvania 18018-3524, USA
www.bbraunusa.com | Send Inquiry | Phone: +1-(610)-691-5400
FDA Registration: 2523676 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~600 Quality: ISO 9000, CE Certified
Products: Procedure Trays, Caps, Disposable Needles, IV Catheters & Infusion Sets, IV Sets, General Medical Supplies, ...
B. Braun Medical Inc. offers medical products. Our product categories are admixture products, dialysis products, infusion pump systems & sets, urology sets & solutions, pain control products and vascu more...
www.bbraunusa.com | Send Inquiry | Phone: +1-(610)-691-5400
FDA Registration: 2523676 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~600 Quality: ISO 9000, CE Certified
Products: Procedure Trays, Caps, Disposable Needles, IV Catheters & Infusion Sets, IV Sets, General Medical Supplies, ...
B. Braun Medical Inc. offers medical products. Our product categories are admixture products, dialysis products, infusion pump systems & sets, urology sets & solutions, pain control products and vascu more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Merit Medical Systems, Inc. | Address: 1600 West Merit Parkway, South Jordan, Utah 84095, USA
www.merit.com | Send Inquiry | Phone: +1-(801)-253-1600
FDA Registration: 1721504 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1700 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Guide Catheters, Inflation Devices, Angioplasty Accessories, Pericardiocentesis Drainage Catheters, Diagnostic Guide Wires, ...
Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic more...
www.merit.com | Send Inquiry | Phone: +1-(801)-253-1600
FDA Registration: 1721504 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1700 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Guide Catheters, Inflation Devices, Angioplasty Accessories, Pericardiocentesis Drainage Catheters, Diagnostic Guide Wires, ...
Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic more...
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FDA Code / Regulation: GBX / 878.4200
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 878.9.
