FDA product code NIQ: Coronary Drug-Eluting Stent
NIQ is the FDA product code for coronary drug-eluting stent. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NIQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 16 PMA applications cite this product code. FDA has posted 6 recalls for NIQ devices.
Definition
Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Classification
| Field | Value |
|---|---|
| Device name | Coronary Drug-Eluting Stent |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NIQ devices
6 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-03-25.
| Year | Recalls |
|---|---|
| 2020 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch
- C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch
Frequently asked questions
What is FDA product code NIQ?
NIQ is the FDA product code for coronary drug-eluting stent. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NIQ?
Class III. Typical premarket route: PMA.
Have NIQ devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2020-03-25.
Next steps
- Run an FDA pathway report with predicate devices for product code NIQ
- Run a recall and safety report across every NIQ manufacturer
- Watch product code NIQ 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.