Infusion 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, Catheter Introducers (FDA Code: DYB), ...
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, Catheter Introducers (FDA Code: DYB), ...
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...
Alsius Corporation | Address: 15770 Laguna Canyon Road, Suite 150, Irvine, California 92618, USA
www.alsius.com | Send Inquiry | Phone: +1-(949)-453-0150, 877-225-7487
Products: Thermal Regulatory Systems, Catheters, Central Venous Catheters, Swan Ganz Catheters, IV Catheters, Intravenous Catheters, ...
Alsius Corporation specializes in intravascular thermal regulation technology. Our Icy™ catheter is inserted into the femoral vein and resides in the inferior vena cava. It delivers target tempe more...
www.alsius.com | Send Inquiry | Phone: +1-(949)-453-0150, 877-225-7487
Products: Thermal Regulatory Systems, Catheters, Central Venous Catheters, Swan Ganz Catheters, IV Catheters, Intravenous Catheters, ...
Alsius Corporation specializes in intravascular thermal regulation technology. Our Icy™ catheter is inserted into the femoral vein and resides in the inferior vena cava. It delivers target tempe more...
Medtronic MiniMed, Inc. | Address: 18000 Devonshire Street, Northridge, California 91325-1219, USA
www.minimed.com | Send Inquiry | Phone: +1-(866)-948-6633
FDA Registration: 2032227 Employee Count: ~2000 Quality: ISO 9001, CE Certified
Products: Blood Glucose Meters, Volumetric Infusion Pumps, Thrombectomy Devices, Infusion Catheter, Infusion Pumps, Ambulatory Pumps, Infusion Catheter (FDA Code: JCY), PCA Pumps, Infusion Pump, ...
Medtronic MiniMed, Inc. deals with diabetes management. Our product list comprises of insulin pump, blood glucose sensor, and therapy adjustment software. Our Paradigm® insulin pump is a small, po more...
www.minimed.com | Send Inquiry | Phone: +1-(866)-948-6633
FDA Registration: 2032227 Employee Count: ~2000 Quality: ISO 9001, CE Certified
Products: Blood Glucose Meters, Volumetric Infusion Pumps, Thrombectomy Devices, Infusion Catheter, Infusion Pumps, Ambulatory Pumps, Infusion Catheter (FDA Code: JCY), PCA Pumps, Infusion Pump, ...
Medtronic MiniMed, Inc. deals with diabetes management. Our product list comprises of insulin pump, blood glucose sensor, and therapy adjustment software. Our Paradigm® insulin pump is a small, po 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, Masks & Breathing Bags, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Irrigating Solutions, Integrated Anesthesia Machines, ...
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, Masks & Breathing Bags, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Irrigating Solutions, Integrated Anesthesia Machines, ...
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...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Needles, Guidewires, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Needles, Guidewires, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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...
DePuy Orthopaedics, Inc | Address: 700 Orthopaedic Drive, Warsaw, Indiana 46582, USA
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Orthopedic Cushions, Probes (FDA Code: HXB), Sutures, Old Plating Systems, Compression Hip Screw Systems, Plating Systems, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Orthopedic Cushions, Probes (FDA Code: HXB), Sutures, Old Plating Systems, Compression Hip Screw Systems, Plating Systems, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
Ranfac Corp. | Address: 30 Doherty Avenue, P.O. Box 635, Avon, Massachusetts 02322, USA
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Hypodermic Needles, Catheter Stylets (FDA Code: DRB), Thrombectomy Devices, Infusion Catheter, Infusion Catheter (FDA Code: JCY), Reusable Hypodermic Needles, Stainless Steel Brain Biopsy Needles, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog more...
www.ranfac.com | Send Inquiry | Phone: +1-(508)-588-4400, (800)-272-6322
FDA Registration: 3011555966 Year Established: 1888 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO, CE Certified
Products: Hypodermic Needles, Catheter Stylets (FDA Code: DRB), Thrombectomy Devices, Infusion Catheter, Infusion Catheter (FDA Code: JCY), Reusable Hypodermic Needles, Stainless Steel Brain Biopsy Needles, ...
Ranfac Corp. supplies precision medical instruments for surgeons, radiologists and hematologists. Our product list comprises of disposable cholangiography catheters, percutaneous introducers, galactog 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: Anesthesia Equipment, Hypodermic Syringes, Bodyfat Analyzers, Medical Thermometers, Blades, Scalpels, ...
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: Anesthesia Equipment, Hypodermic Syringes, Bodyfat Analyzers, Medical Thermometers, Blades, Scalpels, ...
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...
Integra LifeSciences Corporation | Address: 311 Enterprise Drive, Plainsboro, New Jersey 08536, USA
www.integra-ls.com | Send Inquiry | Phone: +1-(609)-275-0500
FDA Registration: 3003418325 Year Established: 1989 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~2500 Quality: CE Certified
Products: Elevators, Retractors, Scissors, Disposables, Dermatomes, Bipolar Forceps, ...
Integra LifeSciences Corporation develops & markets surgical instruments, as well as devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. Our S more...
www.integra-ls.com | Send Inquiry | Phone: +1-(609)-275-0500
FDA Registration: 3003418325 Year Established: 1989 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~2500 Quality: CE Certified
Products: Elevators, Retractors, Scissors, Disposables, Dermatomes, Bipolar Forceps, ...
Integra LifeSciences Corporation develops & markets surgical instruments, as well as devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. Our S more...
E-Z-EM Inc. | Address: 1111 Marcus Avenue Suite LL26, Lake Success, New York 11042, USA
www.ezem.com | Send Inquiry | Phone: +1-(516)-333-8230
FDA Registration: 2411512 Year Established: 1962
Products: Contract Manufacturers, Needles, Gastroenterologic Needle Holder (FDA Code: FHQ), X-Ray Aids, Diagnostic Aids, Biopsy Supplies, ...
E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our more...
www.ezem.com | Send Inquiry | Phone: +1-(516)-333-8230
FDA Registration: 2411512 Year Established: 1962
Products: Contract Manufacturers, Needles, Gastroenterologic Needle Holder (FDA Code: FHQ), X-Ray Aids, Diagnostic Aids, Biopsy Supplies, ...
E-Z-EM Inc manufactures products used for imaging the gastrointestinal tract. Our product ranges from a disposable barium enema administration kit to advanced CT and virtual colonoscopy products. Our 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, Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, Catheter Introducers (FDA Code: DYB), Urethral Catheters (FDA Code: GBM), Caps, ...
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, Angiographic Catheter, Pigtail Diagnostic Catheters, El Gamal Angiographic Catheter, Catheter Introducers (FDA Code: DYB), Urethral Catheters (FDA Code: GBM), Caps, ...
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...
Arrow International, Inc. | Address: PO Box 12888,2400 Bernville Road, Reading, Pennsylvania 19605, USA
www.arrowintl.com | Phone: +1-(610)-655-8522
FDA Registration: 2518433 Year Established: 1975 Annual Revenues: USD 100-500 Million Employee Count: ~3250 Quality: ISO 9000, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Intra-Aortic Balloon Pumps, Endotracheal Tubes, Nebulizers, Oxygen Aids, ...
Arrow International, Inc. combines technology and product innovation to extend the use of catheterization for the diagnosis & treatment of critically ill patients. Our disposable critical care cathete more...
www.arrowintl.com | Phone: +1-(610)-655-8522
FDA Registration: 2518433 Year Established: 1975 Annual Revenues: USD 100-500 Million Employee Count: ~3250 Quality: ISO 9000, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Intra-Aortic Balloon Pumps, Endotracheal Tubes, Nebulizers, Oxygen Aids, ...
Arrow International, Inc. combines technology and product innovation to extend the use of catheterization for the diagnosis & treatment of critically ill patients. Our disposable critical care cathete more...
Cardiac Science, Inc. | Address: 3303 Monte Villa Parkway, Bothell, Washington 98021, USA
www.cardiacscience.com | Send Inquiry | Phone: +1-(425)-402-2000
FDA Registration: 3005064998 Year Established: 1991 Annual Revenues: USD 50-100 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Defibrillators, Spirometers, Otoscopes, Automated External Defibrillators (AEDs), Ambulatory BP Monitors, Holter ECG Monitors, ...
Cardiac Science, Inc. deals with development, manufacture, and marketing of diagnostic & therapeutic cardiology products & services. Our product list comprises of defibrillators, EEG systems, stress t more...
www.cardiacscience.com | Send Inquiry | Phone: +1-(425)-402-2000
FDA Registration: 3005064998 Year Established: 1991 Annual Revenues: USD 50-100 Million Employee Count: ~250 Quality: ISO 9001, CE Certified
Products: Defibrillators, Spirometers, Otoscopes, Automated External Defibrillators (AEDs), Ambulatory BP Monitors, Holter ECG Monitors, ...
Cardiac Science, Inc. deals with development, manufacture, and marketing of diagnostic & therapeutic cardiology products & services. Our product list comprises of defibrillators, EEG systems, stress t more...
CW Medical, Inc. | Address: 5595 Daniels Street, Suite E, Chino, California 91710, USA
www.cwmedical.us | Send Inquiry | Phone: +1-(909)-591-5220
Year Established: 1994 Annual Revenues: USD 1-5 Million
Products: Oxygen Masks (FDA Code: BYG), Headrest System, Urine Collection Leg Bags (FDA Code: FAQ), Fistula Needle (FDA Code: FIE), Surgical Drapes & Packs (FDA Code: KKX), Suction Catheter, ...
CW Medical Inc is a manufacturer and distributor of respiratory and general consumable products. Our health devices include digital dual channel TENS, mini TENS, moist heating pack, instant hand sanit more...
www.cwmedical.us | Send Inquiry | Phone: +1-(909)-591-5220
Year Established: 1994 Annual Revenues: USD 1-5 Million
Products: Oxygen Masks (FDA Code: BYG), Headrest System, Urine Collection Leg Bags (FDA Code: FAQ), Fistula Needle (FDA Code: FIE), Surgical Drapes & Packs (FDA Code: KKX), Suction Catheter, ...
CW Medical Inc is a manufacturer and distributor of respiratory and general consumable products. Our health devices include digital dual channel TENS, mini TENS, moist heating pack, instant hand sanit more...
Therox, Inc. | Address: 17500 Cartwright Rd Suite 100, Irvine, California 92614, USA
www.therox.com | Send Inquiry | Phone: +1-(949)-757-1999
Products: Infusion Catheter (FDA Code: JCY), Cartridges, Diagnostic Intravascular Catheter (FDA Code: DQO), Aqueous Oxygen Systems, Aqueous Oxygen (AO) Cartridges, AO Catheters, ...
Therox, Inc. offers AO system, disposables and DownStream® system. Our SSO2 therapy complements percutaneous coronary intervention. It delivers superoxygenated arterial blood, which can lead to re more...
www.therox.com | Send Inquiry | Phone: +1-(949)-757-1999
Products: Infusion Catheter (FDA Code: JCY), Cartridges, Diagnostic Intravascular Catheter (FDA Code: DQO), Aqueous Oxygen Systems, Aqueous Oxygen (AO) Cartridges, AO Catheters, ...
Therox, Inc. offers AO system, disposables and DownStream® system. Our SSO2 therapy complements percutaneous coronary intervention. It delivers superoxygenated arterial blood, which can lead to re more...
I-Flow Corporation | Address: 20202 Windrow Dr., Lake Forest, California 92630, USA
www.I-flowcorp.com | Send Inquiry | Phone: +1-(949)-206-2700, 800-448-3569
FDA Registration: 2026095 Year Established: 1985 Annual Revenues: USD 25-50 Million Employee Count: ~70 Quality: ISO 9000, ISO 9001, CE Certified
Products: Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), Ambulatory Infusion Pumps, Anesthetic Infusion Pump (FDA Code: FRN), Piston Syringe (FDA Code: FMF), Peristaltic Infusion Pump (FDA Code: FRN), ...
I-Flow Corporation designs, develops and markets technically advanced drug delivery systems that redefine the standard of care by providing life enhancing, cost effective solutions for pain relief. We more...
www.I-flowcorp.com | Send Inquiry | Phone: +1-(949)-206-2700, 800-448-3569
FDA Registration: 2026095 Year Established: 1985 Annual Revenues: USD 25-50 Million Employee Count: ~70 Quality: ISO 9000, ISO 9001, CE Certified
Products: Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), Ambulatory Infusion Pumps, Anesthetic Infusion Pump (FDA Code: FRN), Piston Syringe (FDA Code: FMF), Peristaltic Infusion Pump (FDA Code: FRN), ...
I-Flow Corporation designs, develops and markets technically advanced drug delivery systems that redefine the standard of care by providing life enhancing, cost effective solutions for pain relief. We more...
Venetec International, Inc. | Address: 12555 High Bluff Drive, Suite 100, San Diego, California 92130, USA
venetec.com | Send Inquiry | Phone: +1-(858)-350-4444, 800-833-3895
Annual Revenues: USD 5-10 Million Employee Count: ~70
Products: Intrauterine Insemination Catheters (IUI), Thermistor Ablation Catheters, IVUS Catheters, Right Coronary Diagnostic Catheters, Amplatz II Brachial, Coronary Guide Catheters, Wexler Arterial Bypass, Catheters, ...
Venetec International, Inc. supplies medical products. We specialize in catheter securement technology. Our Statlock® devices protect patients and healthcare workers by reducing potential complica more...
venetec.com | Send Inquiry | Phone: +1-(858)-350-4444, 800-833-3895
Annual Revenues: USD 5-10 Million Employee Count: ~70
Products: Intrauterine Insemination Catheters (IUI), Thermistor Ablation Catheters, IVUS Catheters, Right Coronary Diagnostic Catheters, Amplatz II Brachial, Coronary Guide Catheters, Wexler Arterial Bypass, Catheters, ...
Venetec International, Inc. supplies medical products. We specialize in catheter securement technology. Our Statlock® devices protect patients and healthcare workers by reducing potential complica more...
Advanced Infusion, Inc. | Address: 466 West Arrow Highway, Unit H, San Dimas, California 91773, USA
www.advancedinfusion.com | Send Inquiry | Phone: +1-(904)-394-4916
Products: Infusion Catheter (FDA Code: JCY), Pain Management System, General Surgical Manual Instrument (FDA Code: MDM), Elastomeric Infusion Pump (FDA Code: MEB), Anesthesia Catheters, Attachable Infusion Catheters, ...
Advanced Infusion, Inc. specializes in developing, manufacturing and distributing products for the relief of post-operative pain. Our catheters include Alpha Cath™, Multi Drip™, and anesth more...
www.advancedinfusion.com | Send Inquiry | Phone: +1-(904)-394-4916
Products: Infusion Catheter (FDA Code: JCY), Pain Management System, General Surgical Manual Instrument (FDA Code: MDM), Elastomeric Infusion Pump (FDA Code: MEB), Anesthesia Catheters, Attachable Infusion Catheters, ...
Advanced Infusion, Inc. specializes in developing, manufacturing and distributing products for the relief of post-operative pain. Our catheters include Alpha Cath™, Multi Drip™, and anesth more...
Vascular Designs, Inc. | Address: 4960 Almaden Expressway, San Jose, California 95120, USA
www.vasculardesigns.com | Phone: +1-(408)-230-5560
Products: Catheters, Balloon Catheters, Infusion Catheter (FDA Code: JCY), Percutaneous Catheter (FDA Code: DQY), Continuous Flush Catheter (FDA Code: KRA), Infusion Catheter Systems, ...
Vascular Designs, Inc. deals with Isoflow™ infusion catheter system, which is used for cancer treatment. Our Isoflow™ is a dual balloon catheter that is designed to isolate a specific trea more...
www.vasculardesigns.com | Phone: +1-(408)-230-5560
Products: Catheters, Balloon Catheters, Infusion Catheter (FDA Code: JCY), Percutaneous Catheter (FDA Code: DQY), Continuous Flush Catheter (FDA Code: KRA), Infusion Catheter Systems, ...
Vascular Designs, Inc. deals with Isoflow™ infusion catheter system, which is used for cancer treatment. Our Isoflow™ is a dual balloon catheter that is designed to isolate a specific trea more...
Vascular Insights Llc | Address: 395 Boston Post Rd., Madison, Connecticut 06443, USA
www.vascularinsights.com | Send Inquiry | Phone: +1-(203)-376-3775
Products: Balloon Catheters, Infusion Catheter (FDA Code: JCY), Reagents, Therapeutic Device Development, Continuous Renal Replacement Therapy, Disposable Reagent Set, ...
Vascular Insights Llc deals with medical devices for the treatment of vascular diseases. ClariVein™ is a percutaneous infusion catheter that contains a rotating wire driven by a motor activated more...
www.vascularinsights.com | Send Inquiry | Phone: +1-(203)-376-3775
Products: Balloon Catheters, Infusion Catheter (FDA Code: JCY), Reagents, Therapeutic Device Development, Continuous Renal Replacement Therapy, Disposable Reagent Set, ...
Vascular Insights Llc deals with medical devices for the treatment of vascular diseases. ClariVein™ is a percutaneous infusion catheter that contains a rotating wire driven by a motor activated more...
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FDA Code / Regulation: JCY / 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.
