FDA product code NIV: Coronary Covered Stent
NIV is the FDA product code for coronary covered stent. It is a HDE device, reviewed by the Cardiovascular panel. Devices under NIV reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.
Classification
| Field | Value |
|---|---|
| Device name | Coronary Covered Stent |
| Device class | HDE |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for NIV devices
openFDA lists no recalls for product code NIV.
Frequently asked questions
What is FDA product code NIV?
NIV is the FDA product code for coronary covered stent. It is a HDE device, reviewed by the Cardiovascular panel.
What device class is NIV?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code NIV
- Run a recall and safety report across every NIV manufacturer
- Watch product code NIV 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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