Balloon Type Catheter Suppliers
Limit companies to: Worldwide USA
Rece International Corp. | Address: 5881 N.W. 151st St., Ste. 111, Miami Lakes, Florida 33014, USA 
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Medline Industries, Inc. | Address: One Medline Place, Mundelein, Illinois 60060, USA
www.medline.com | Send Inquiry | Phone: +1-(800)-633-5463
FDA Registration: 1417592 Year Established: 1966 Annual Revenues: < USD 1 Million Employee Count: ~6800 Quality: ISO 13485 and ISO 11135 Certified
Products: Autoclaves, Scissors, Instrument Stands, Thermometers, Endotracheal Tubes, Aspirators, ...
Medline Industries, Inc. is a manufacturer and distributor of health care supplies & services. We provide products and services to the entire continuum of care, including hospitals, extended care faci more...
www.medline.com | Send Inquiry | Phone: +1-(800)-633-5463
FDA Registration: 1417592 Year Established: 1966 Annual Revenues: < USD 1 Million Employee Count: ~6800 Quality: ISO 13485 and ISO 11135 Certified
Products: Autoclaves, Scissors, Instrument Stands, Thermometers, Endotracheal Tubes, Aspirators, ...
Medline Industries, Inc. is a manufacturer and distributor of health care supplies & services. We provide products and services to the entire continuum of care, including hospitals, extended care faci more...
Telemed Systems Inc. | Address: 8 Kane Industrial Drive, Hudson, Massachusetts 01749, USA
www.telemedsystems.com | Send Inquiry | Phone: +1-(978)-567-9033, 800-481-6718
FDA Registration: 1222168 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Biopsy Forceps, Cytology Brushes, Balloon Catheters, Biopsy Instruments (FDA Code: KNW), Disposable Biopsy Forceps, Biliary Dilatation Kit, ...
Telemed Systems Inc. is manufacturer of medical accessory devices which are utilized with the flexible endoscope in the field of gastroenterology. Our product line includes polypectomy snares, gastroi more...
www.telemedsystems.com | Send Inquiry | Phone: +1-(978)-567-9033, 800-481-6718
FDA Registration: 1222168 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Biopsy Forceps, Cytology Brushes, Balloon Catheters, Biopsy Instruments (FDA Code: KNW), Disposable Biopsy Forceps, Biliary Dilatation Kit, ...
Telemed Systems Inc. is manufacturer of medical accessory devices which are utilized with the flexible endoscope in the field of gastroenterology. Our product line includes polypectomy snares, gastroi more...
Boston Scientific Corporation | Address: One Boston Scientific Place, Natick, Massachusetts 01760-1537, USA
www.bostonscientific.com | Phone: +1-(508)-650-8000
FDA Registration: 1828132
Products: Active Fixation Steroid Eluting, Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Ablation Catheter, Alligator Jaw-step Biopsy Forceps, Angiographic Catheter, ...
Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division co more...
www.bostonscientific.com | Phone: +1-(508)-650-8000
FDA Registration: 1828132
Products: Active Fixation Steroid Eluting, Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Ablation Catheter, Alligator Jaw-step Biopsy Forceps, Angiographic Catheter, ...
Boston Scientific Corporation specializes in the development, manufacturing and marketing of medical devices. We also design and produce cardiovascular medical products. Our cardiovascular division co more...
Insitu Technologies, Inc. | Address: 5810 Blackshire Path, Inver Grove Heights, Minnesota 55076, USA
www.insitu-tech.com | Send Inquiry | Phone: +1-(651)-389-1017
FDA Registration: 2134244
Products: Coronary Stent (FDA Code: MAF), Catheter Cannula (FDA Code: DQR), Balloon Type Catheter (FDA Code: GBA), Coronary Drug-Eluting Stent (FDA Code: NIQ), Angiography/Angioplasty Kit (FDA Code: OEQ), Coronary Covered Stent (FDA Code: NIV), ...
InSitu Technologies Inc. is a privately held medical device company specializing in intra-vascular stents and cardiovascular products. Our products include cardiovascular stents, peripheral stents, re more...
www.insitu-tech.com | Send Inquiry | Phone: +1-(651)-389-1017
FDA Registration: 2134244
Products: Coronary Stent (FDA Code: MAF), Catheter Cannula (FDA Code: DQR), Balloon Type Catheter (FDA Code: GBA), Coronary Drug-Eluting Stent (FDA Code: NIQ), Angiography/Angioplasty Kit (FDA Code: OEQ), Coronary Covered Stent (FDA Code: NIV), ...
InSitu Technologies Inc. is a privately held medical device company specializing in intra-vascular stents and cardiovascular products. Our products include cardiovascular stents, peripheral stents, re more...
Cartika Medical, Inc. | Address: 6550 Wedgwood Rd. N., Suite 300, Maple Grove, Minnesota 55311, USA
www.cartikamedical.com | Send Inquiry | Phone: +1-(763)-545-5188
FDA Registration: 2134914
Products: Feeding Tubes (FDA Code: FPD), Steerable Catheter (FDA Code: DRA), Balloon Type Catheter (FDA Code: GBA), Catheter Dilator (FDA Code: GCC), Multiple Lumen Catheter (FDA Code: GBP), ...
Cartika Medical, Inc. is a developer and manufacturer of catheters, tubing and medical components. We are an ISO 13485 and ISO 9001:2008 certified company. Our product line includes braided and non-br more...
www.cartikamedical.com | Send Inquiry | Phone: +1-(763)-545-5188
FDA Registration: 2134914
Products: Feeding Tubes (FDA Code: FPD), Steerable Catheter (FDA Code: DRA), Balloon Type Catheter (FDA Code: GBA), Catheter Dilator (FDA Code: GCC), Multiple Lumen Catheter (FDA Code: GBP), ...
Cartika Medical, Inc. is a developer and manufacturer of catheters, tubing and medical components. We are an ISO 13485 and ISO 9001:2008 certified company. Our product line includes braided and non-br more...
Via Biomedical, Inc. | Address: 6655 Wedgwood Rd, Suite 150, Osseo, Minnesota 55311, USA
Products: Balloon Catheters, Catheter Accessories (FDA Code: KGZ), Percutaneous Catheter (FDA Code: DQY), Temporary Intravascular Occluding Catheter (FDA Code: MJN), Balloon Type Catheter (FDA Code: GBA), ...
Via Biomedical, Inc. catheter-based systems including delivery systems, balloon catheters and catheter accessories. more...
Products: Balloon Catheters, Catheter Accessories (FDA Code: KGZ), Percutaneous Catheter (FDA Code: DQY), Temporary Intravascular Occluding Catheter (FDA Code: MJN), Balloon Type Catheter (FDA Code: GBA), ...
Via Biomedical, Inc. catheter-based systems including delivery systems, balloon catheters and catheter accessories. more...
Spineology Inc. | Address: 7200 Hudson Blvd. N., Suite 205, Saint Paul, Minnesota 55128, USA
www.spineology.com | Send Inquiry | Phone: +1-(651)-2568500, 888 377 4633
FDA Registration: 2135156 Year Established: 1996
Products: General Surgical Manual Instrument (FDA Code: MDM), Cement Restrictor Hip Prosthesis (FDA Code: JDK), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Metal Mesh (FDA Code: EZX), Orthopedic Blades, Orthopedic Resectors, ...
Spineology Inc. provides spinal implants and grafting products. OptiMesh is a spinal implant that provides pain relief. OptiMesh is a minimally invasive grafting system for lumbar interbody fusion. Op more...
www.spineology.com | Send Inquiry | Phone: +1-(651)-2568500, 888 377 4633
FDA Registration: 2135156 Year Established: 1996
Products: General Surgical Manual Instrument (FDA Code: MDM), Cement Restrictor Hip Prosthesis (FDA Code: JDK), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Metal Mesh (FDA Code: EZX), Orthopedic Blades, Orthopedic Resectors, ...
Spineology Inc. provides spinal implants and grafting products. OptiMesh is a spinal implant that provides pain relief. OptiMesh is a minimally invasive grafting system for lumbar interbody fusion. Op more...
Guidant Corporation | Address: 4100 Hamline Avenue North, St. Paul, Minnesota 55112-5798, USA
www.guidant.com | Phone: +1-(651)-582-4000
Annual Revenues: USD 50-100 Million Employee Count: ~320 Quality: ISO 9001, CE Certified
Products: Guidewires, Implantable Cardiac Defibrillators, Coronary Dilation Balloons, Coronary Dilatation Catheter, Ablation System, Endoscopic Vessel Harvesting System, Guiding Catheter, ...
Guidant Corporation is involved in the design and development of cardiovascular medical products. We offer products for the treatment of arrhythmias, heart failure, coronary artery and peripheral vasc more...
www.guidant.com | Phone: +1-(651)-582-4000
Annual Revenues: USD 50-100 Million Employee Count: ~320 Quality: ISO 9001, CE Certified
Products: Guidewires, Implantable Cardiac Defibrillators, Coronary Dilation Balloons, Coronary Dilatation Catheter, Ablation System, Endoscopic Vessel Harvesting System, Guiding Catheter, ...
Guidant Corporation is involved in the design and development of cardiovascular medical products. We offer products for the treatment of arrhythmias, heart failure, coronary artery and peripheral vasc more...
NuMed, Inc. | Address: 2880 Main St., Hopkinton, New York 12965, USA
www.numedforchildren.com | Send Inquiry | Phone: +1-(315)-328-4491
FDA Registration: 1318694 Year Established: 1982 Annual Revenues: USD 50-100 Million Employee Count: ~20 Quality: ISO 13485:2003 Certified
Products: Balloon Catheters, Peripheral Dilatation Catheter, Angiographic Catheter, Balloon Type Cardiovascular Catheter, Percutaneous Valvuloplasty Catheter (FDA Code: MAD), Balloon Type Catheter (FDA Code: GBA), ...
NuMed, Inc. specializes in vascular interventional products. We offer a full line of percutaneous transluminal angioplasty (PTA), percutaneous transluminal valvuloplasty (PTV), atrioseptostomy, sizing more...
www.numedforchildren.com | Send Inquiry | Phone: +1-(315)-328-4491
FDA Registration: 1318694 Year Established: 1982 Annual Revenues: USD 50-100 Million Employee Count: ~20 Quality: ISO 13485:2003 Certified
Products: Balloon Catheters, Peripheral Dilatation Catheter, Angiographic Catheter, Balloon Type Cardiovascular Catheter, Percutaneous Valvuloplasty Catheter (FDA Code: MAD), Balloon Type Catheter (FDA Code: GBA), ...
NuMed, Inc. specializes in vascular interventional products. We offer a full line of percutaneous transluminal angioplasty (PTA), percutaneous transluminal valvuloplasty (PTV), atrioseptostomy, sizing more...
Polyzen, Inc. | Address: 1041 Classic Road, Apex, North Carolina 27539, USA
www.polyzen.com | Send Inquiry | Phone: +1-(919)-319-9599
FDA Registration: 1064859 Year Established: 1991 Employee Count: ~60 Quality: ISO Certified
Products: Balloon Catheters, Condoms, Wound Care Dressings, Film, Balloon Type Catheter (FDA Code: GBA), Wound Dressing Kit (FDA Code: MCY), ...
Polyzen, Inc. is a developer and manufacturer of disposable medical products & devices for the medical industry. Our products include specialty condoms, tissue collection bags, urethane bladders, bell more...
www.polyzen.com | Send Inquiry | Phone: +1-(919)-319-9599
FDA Registration: 1064859 Year Established: 1991 Employee Count: ~60 Quality: ISO Certified
Products: Balloon Catheters, Condoms, Wound Care Dressings, Film, Balloon Type Catheter (FDA Code: GBA), Wound Dressing Kit (FDA Code: MCY), ...
Polyzen, Inc. is a developer and manufacturer of disposable medical products & devices for the medical industry. Our products include specialty condoms, tissue collection bags, urethane bladders, bell more...
Bausch & Lomb Inc. | Address: 8507 Pelham Rd., Greenville, South Carolina 29615-9598, USA
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Toray International America Inc. | Address: 140 Cypress Station Dr., Ste. 210, Houston, Texas 77090, USA
www.torayusa.com | Send Inquiry | Phone: +1-(281)-587-2299, 800-662-1777
FDA Registration: 1649869
Products: X-Ray Protective Eyewear, Balloon Catheters, Guidewire Catheter (FDA Code: DQX), Percutaneous Valvuloplasty Catheter (FDA Code: MAD), Balloon Type Catheter (FDA Code: GBA), ...
Toray International America Inc. offers Inoue-Balloon catheters. They are indicated for percutaneous transvenous mitral commissurotomy (PTMC) in patients with hemodynamically significant mitral valvul more...
www.torayusa.com | Send Inquiry | Phone: +1-(281)-587-2299, 800-662-1777
FDA Registration: 1649869
Products: X-Ray Protective Eyewear, Balloon Catheters, Guidewire Catheter (FDA Code: DQX), Percutaneous Valvuloplasty Catheter (FDA Code: MAD), Balloon Type Catheter (FDA Code: GBA), ...
Toray International America Inc. offers Inoue-Balloon catheters. They are indicated for percutaneous transvenous mitral commissurotomy (PTMC) in patients with hemodynamically significant mitral valvul more...
Unomedical, Inc. | Address: 5701-1 S. Ware Rd, McAllen, Texas 78503, USA
www.unomedical.us | Send Inquiry | Phone: +1-(956)-683-8472
Annual Revenues: USD 50-100 Million Employee Count: ~600 Quality: ISO 9001, ISO 9002, CE Certified
Products: Anesthesia Circuit, Bacterial & Viral Filters, Aerosol Mask, Anesthesia Breathing Circuit Accessories, Anesthetic Gas Mask (FDA Code: BSJ), Breathing Circuit Bacterial Filter (FDA Code: CAH), Balloon Type Catheter (FDA Code: GBA), ...
Unomedical, Inc. specializes in the manufacturing and distribution of medical single-use devices which include anesthesia, respiratory care, urology catheters, electrodes, urine bags, suction catheter more...
www.unomedical.us | Send Inquiry | Phone: +1-(956)-683-8472
Annual Revenues: USD 50-100 Million Employee Count: ~600 Quality: ISO 9001, ISO 9002, CE Certified
Products: Anesthesia Circuit, Bacterial & Viral Filters, Aerosol Mask, Anesthesia Breathing Circuit Accessories, Anesthetic Gas Mask (FDA Code: BSJ), Breathing Circuit Bacterial Filter (FDA Code: CAH), Balloon Type Catheter (FDA Code: GBA), ...
Unomedical, Inc. specializes in the manufacturing and distribution of medical single-use devices which include anesthesia, respiratory care, urology catheters, electrodes, urine bags, suction catheter more...
Shenzhen Medoo Medical Tech.Co.,Ltd. | Address: Room 401, A407-B402, B415-B420, Platform Building, Key Laboratory, Virtual University Park, Yuexing, Street, Nanshan District, Shenzhen, Guangdong, China 
www.medoo.hk | Send Inquiry | Phone: +86-(755)-26928966
Products: Balloon Catheters, Urethral Dilation Balloon Catheters, Balloon Type Cardiovascular Catheter, Balloon Type Catheter (FDA Code: GBA), Biliary Balloon Dilatation Catheters, Balloon Catheter Assemblies, ...
Shenzhen Medoo Medical Tech.Co.,Ltd. specializes in design, development, manufacture and sales of advanced medical devices. Semi-compliant pre-dilatation balloon catheter with diameter sizes of 1.0mm- more...
www.medoo.hk | Send Inquiry | Phone: +86-(755)-26928966
Products: Balloon Catheters, Urethral Dilation Balloon Catheters, Balloon Type Cardiovascular Catheter, Balloon Type Catheter (FDA Code: GBA), Biliary Balloon Dilatation Catheters, Balloon Catheter Assemblies, ...
Shenzhen Medoo Medical Tech.Co.,Ltd. specializes in design, development, manufacture and sales of advanced medical devices. Semi-compliant pre-dilatation balloon catheter with diameter sizes of 1.0mm- more...
Rusch (UK) Ltd. | Address: Halifax Rd., Cressex Industrial Estat, High Wycombe, Bucks. HP12 3NB, United Kingdom 
Phone: +44-(1494)-532-761
Employee Count: ~150 Quality: ISO 9000, CE Certified
Products: Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ), Adult Elongated Mask with Corrugated Tubing, Face Tent with Corrugated Tubing, Corrugated Tubing, Reusable Leg Bags, Corrugated Tubing Adapter, ...
Rusch (UK) Ltd. supplies a broad range of invasive & noninvasive, disposable and reusable devices to the anesthesiology, urology, gastroenterology, and respiratory care markets. We offer various urolo more...
Phone: +44-(1494)-532-761
Employee Count: ~150 Quality: ISO 9000, CE Certified
Products: Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ), Adult Elongated Mask with Corrugated Tubing, Face Tent with Corrugated Tubing, Corrugated Tubing, Reusable Leg Bags, Corrugated Tubing Adapter, ...
Rusch (UK) Ltd. supplies a broad range of invasive & noninvasive, disposable and reusable devices to the anesthesiology, urology, gastroenterology, and respiratory care markets. We offer various urolo more...
Panpac Medical Corporation | Address: No. 202, 6f-1.2, Sec.3, Tatong Road, Shi-Chih City, Taipei Hsien, Taiwan 
Phone: +886-(2)-86472242
FDA Registration: 3003968049
Products: Vaginal Dilators (FDA Code: HDX), Uterine Sounds (FDA Code: HHM), Endometrial Suction Curette and Accessories (FDA Code: HHK), Fixed Size Cervical Dilator (FDA Code: HDQ), Uterine Manipulator/Injector Cannula (FDA Code: LKF), Vaginal Pessary (FDA Code: HHW), ...
Panpac Medical Corporation is a manufacturer of balloon type catheters, uterine sounds, vaginal dilators and neonatal eye pads. more...
Phone: +886-(2)-86472242
FDA Registration: 3003968049
Products: Vaginal Dilators (FDA Code: HDX), Uterine Sounds (FDA Code: HHM), Endometrial Suction Curette and Accessories (FDA Code: HHK), Fixed Size Cervical Dilator (FDA Code: HDQ), Uterine Manipulator/Injector Cannula (FDA Code: LKF), Vaginal Pessary (FDA Code: HHW), ...
Panpac Medical Corporation is a manufacturer of balloon type catheters, uterine sounds, vaginal dilators and neonatal eye pads. more...
Nolato Medevo AB | Address: Po Box 66, Torekov 26093, Sweden
www.nolato.se | Send Inquiry | Phone: +46-(431)-44-22-60
FDA Registration: 8030941 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO 9001, ISO 14001, ISO 13485 Certified
Products: Reservoir Bag (FDA Code: BTC), Balloon Type Catheter (FDA Code: GBA), Contract Manufacturing, Product Modification Service, Rubber Component, ...
Nolato Medevo AB develops, manufactures and processes injection-molded component systems in collaboration with customers in the pharmaceutical & medical device industries. We manufacture dipped latex more...
www.nolato.se | Send Inquiry | Phone: +46-(431)-44-22-60
FDA Registration: 8030941 Annual Revenues: USD 10-25 Million Employee Count: ~50 Quality: ISO 9001, ISO 14001, ISO 13485 Certified
Products: Reservoir Bag (FDA Code: BTC), Balloon Type Catheter (FDA Code: GBA), Contract Manufacturing, Product Modification Service, Rubber Component, ...
Nolato Medevo AB develops, manufactures and processes injection-molded component systems in collaboration with customers in the pharmaceutical & medical device industries. We manufacture dipped latex more...
Iberhospitex S.A. | Address: Avda. Catalunya 4, Llissa Del Vall, Barcelona E-08185, Spain
www.iberhospitex.com | Send Inquiry | Phone: +34-(93)-843-6034
Annual Revenues: USD 5-10 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Catheter Accessories (FDA Code: KGZ), General Surgical Dressings, Dental Surgical Dressing Material, Chronic Catheter Accessories, Balloon Type Catheter (FDA Code: GBA), Endovascular Stent, ...
Iberhospitex S.A. offers tapes, dressings, catheter protectors, wound drainage, body fluid suction, humidifiers, surgical suction, and incise drapes. Our humidifiers come with articulated monobloc sys more...
www.iberhospitex.com | Send Inquiry | Phone: +34-(93)-843-6034
Annual Revenues: USD 5-10 Million Employee Count: ~100 Quality: ISO 9001, CE Certified
Products: Catheter Accessories (FDA Code: KGZ), General Surgical Dressings, Dental Surgical Dressing Material, Chronic Catheter Accessories, Balloon Type Catheter (FDA Code: GBA), Endovascular Stent, ...
Iberhospitex S.A. offers tapes, dressings, catheter protectors, wound drainage, body fluid suction, humidifiers, surgical suction, and incise drapes. Our humidifiers come with articulated monobloc sys more...
Avalon Medical Services Pte Ltd | Address: 29 Woodlands Industrial Park E1, No. 04-13/14 Northtech Lobby 3, Singapore 757716, Singapore
Phone: +65-(065)-64681456
Products: Balloon Type Catheter (FDA Code: GBA), ...
Avalon Medical Services Pte Ltd is involved in the business of balloon type catheters. more...
Phone: +65-(065)-64681456
Products: Balloon Type Catheter (FDA Code: GBA), ...
Avalon Medical Services Pte Ltd is involved in the business of balloon type catheters. more...
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FDA Code / Regulation: GBA / 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.
