Accessories, A-V Shunt
Arteriovenous Shunt Accessories are components used in conjunction with implanted AV shunts in patients undergoing hemodialysis, including clamps, cannulas, and connection fittings that support the maintenance and use of the vascular access device. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNZ and the applicable regulation is 21 CFR 876.5540 in the Gastroenterology and Urology specialty. This device is an implant.
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Basic Information
- Product Code
- KNZ
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842039 | ARGON DUAL LUMEN HEMODIALYSIS, CATHETER | Jan 29, 1985 | Substantially Equivalent | Argon Medical Corp. |
| K844612 | ACUTE HEMODIALYSIS TRAYS | Dec 17, 1984 | Substantially Equivalent | Packaging Technologies, Inc. |
| K842864 | VACCESS FEMORAL CANNULA | Aug 08, 1984 | Substantially Equivalent | Vas-Cath of Canada , Ltd. |
| K842416 | DUO FLOW CATHETER-MC 54 | Jul 26, 1984 | Substantially Equivalent | Medical Components, Inc. |
| K841530 | DOUBLE LUMEN SUBLCAVIAN-FEMORAL | Jun 25, 1984 | Substantially Equivalent | Medical Components, Inc. |
| K841119 | TOPS DISPOS. INFUSION SET/HEMODIALYSIS | Apr 20, 1984 | Substantially Equivalent | Top Surgical Manufacturers Co. |
| K840424 | HEMOCATH REPAIR KIT | Mar 05, 1984 | Substantially Equivalent | Quinton, Inc. |
| K840437 | HEMASITE ACCESSORIES MODIFICATION | Feb 21, 1984 | Substantially Equivalent | Renal Systems, Inc. |
| K834510 | RENAFLO AVF SET FOR HEMODIALYSIS | Feb 04, 1984 | Substantially Equivalent | Renal Systems, Inc. |
| K833139 | ACUTE HEMODIALYSIS TRAYS | Dec 22, 1983 | Substantially Equivalent | Intermed, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.