FDA product code NIN: Stent, Renal
NIN is the FDA product code for stent, renal. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NIN reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 1 recall for NIN devices.
Definition
Stent, Renal -- a metal scaffold placed via a delivery catheter into the renal artery to maintain the lumen
Classification
| Field | Value |
|---|---|
| Device name | Stent, Renal |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NIN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-04-15.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code NIN?
NIN is the FDA product code for stent, renal. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NIN?
Class III. Typical premarket route: PMA.
Have NIN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code NIN
- Run a recall and safety report across every NIN manufacturer
- Watch product code NIN 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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