FDA product code KNZ: Accessories, A-V Shunt
KNZ is the FDA product code for accessories, a-v shunt. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under KNZ, from 8 different applicants. The average 510(k) review took 64 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Accessories, A-V Shunt |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KNZ clearance
Top KNZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Components, Inc. | 2 | 1984-07-26 |
| Renal Systems, Inc. | 2 | 1984-02-21 |
| Argon Medical Corp. | 1 | 1985-01-29 |
| Packaging Technologies, Inc. | 1 | 1984-12-17 |
| Vas-Cath of Canada , Ltd. | 1 | 1984-08-08 |
3 more applicants have KNZ clearances. See the full list in Caduvo.
Most recent KNZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842039 | Argon Medical Corp. | ARGON DUAL LUMEN HEMODIALYSIS, CATHETER | 1985-01-29 | 253 |
| K844612 | Packaging Technologies, Inc. | ACUTE HEMODIALYSIS TRAYS | 1984-12-17 | 20 |
| K842864 | Vas-Cath of Canada , Ltd. | VACCESS FEMORAL CANNULA | 1984-08-08 | 16 |
| K842416 | Medical Components, Inc. | DUO FLOW CATHETER-MC 54 | 1984-07-26 | 36 |
| K841530 | Medical Components, Inc. | DOUBLE LUMEN SUBLCAVIAN-FEMORAL | 1984-06-25 | 83 |
Recalls for KNZ devices
openFDA lists no recalls for product code KNZ.
Frequently asked questions
What is FDA product code KNZ?
KNZ is the FDA product code for accessories, a-v shunt. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is KNZ?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNZ?
Across 10 cleared submissions the average was 64 days from receipt to decision (median 36).
Which companies have the most KNZ clearances?
Medical Components, Inc. (2); Renal Systems, Inc. (2); Argon Medical Corp. (1); Packaging Technologies, Inc. (1); Vas-Cath of Canada , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KNZ
- Run a recall and safety report across every KNZ manufacturer
- Watch product code KNZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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