FDA product code NIF: Catheter, Hemodialysis, Triple Lumen, Implanted
NIF is the FDA product code for catheter, hemodialysis, triple lumen, implanted. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. Devices under NIF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Hemodialysis, Triple Lumen, Implanted |
| 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 |
| Life-sustaining or supporting | Yes |
Recalls for NIF devices
openFDA lists no recalls for product code NIF.
Frequently asked questions
What is FDA product code NIF?
NIF is the FDA product code for catheter, hemodialysis, triple lumen, implanted. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is NIF?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NIF
- Run a recall and safety report across every NIF manufacturer
- Watch product code NIF 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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