FDA product code NIP: Stent, Superficial Femoral Artery
NIP is the FDA product code for stent, superficial femoral artery. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NIP reach the market by PMA; FDA lists no cleared 510(k)s for it. 13 PMA applications cite this product code. FDA has posted 86 recalls for NIP devices, 2 initiated in the last five years.
Definition
Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Classification
| Field | Value |
|---|---|
| Device name | Stent, Superficial Femoral Artery |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NIP devices
86 product recalls in 12 recall events; 2 initiated in the last five years and 4 still open. Most recent: 2023-11-20.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code NIP?
NIP is the FDA product code for stent, superficial femoral artery. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NIP?
Class III. Typical premarket route: PMA.
Have NIP devices been recalled?
Yes: 86 product recalls across 12 recall events; the most recent began 2023-11-20.
Next steps
- Run an FDA pathway report with predicate devices for product code NIP
- Run a recall and safety report across every NIP manufacturer
- Watch product code NIP 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times