FDA product code FIQ: Cannula, A-V Shunt
FIQ is the FDA product code for cannula, 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 23 510(k) submissions under FIQ, from 12 different applicants. The average 510(k) review took 51 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Cannula, 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 FIQ clearance
Top FIQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Renal Systems, Inc. | 6 | 1984-02-21 |
| Akcess Medical Products, Inc. | 3 | 1989-05-15 |
| Vas-Cath of Canada , Ltd. | 3 | 1984-04-24 |
| Quinton, Inc. | 2 | 1985-01-18 |
| Med-West, Inc. | 2 | 1983-06-03 |
7 more applicants have FIQ clearances. See the full list in Caduvo.
Most recent FIQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K892887 | Akcess Medical Products, Inc. | ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA | 1989-05-15 | 25 |
| K892663 | Akcess Medical Products, Inc. | S-100 ALLEN-BROWN SHUNT | 1989-05-04 | 21 |
| K892666 | Akcess Medical Products, Inc. | SAF-T-SHUNT, S-300 SERIES | 1989-05-04 | 21 |
| K844692 | Quinton, Inc. | PEDIATRIC SIZED HEMOCATH CATHETER | 1985-01-18 | 46 |
| K841791 | Hospal Medical Corp. | PLUME FISTULA NEEDLE | 1984-07-09 | 70 |
Recalls for FIQ devices
openFDA lists no recalls for product code FIQ.
Frequently asked questions
What is FDA product code FIQ?
FIQ is the FDA product code for cannula, 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 FIQ?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIQ?
Across 23 cleared submissions the average was 51 days from receipt to decision (median 34).
Which companies have the most FIQ clearances?
Renal Systems, Inc. (6); Akcess Medical Products, Inc. (3); Vas-Cath of Canada , Ltd. (3); Quinton, Inc. (2); Med-West, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FIQ
- Run a recall and safety report across every FIQ manufacturer
- Watch product code FIQ 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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