FDA product code NIU: Stent, Superficial Femoral Artery, Drug-Eluting
NIU is the FDA product code for stent, superficial femoral artery, drug-eluting. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NIU reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 3 recalls for NIU devices.
Definition
Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Superficial Femoral Artery, Drug-Eluting |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NIU devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-21.
| Year | Recalls |
|---|---|
| 2021 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch
Frequently asked questions
What is FDA product code NIU?
NIU is the FDA product code for stent, superficial femoral artery, drug-eluting. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NIU?
Class III. Typical premarket route: PMA.
Have NIU devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2021-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code NIU
- Run a recall and safety report across every NIU manufacturer
- Watch product code NIU 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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