FDA product code NXW: Scaffold, Infrapopliteal, Absorbable
NXW is the FDA product code for scaffold, infrapopliteal, absorbable. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NXW reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The absorbable scaffold is for improving luminal diameter for the treatment of lesions in native infrapopliteal arteries.
Classification
| Field | Value |
|---|---|
| Device name | Scaffold, Infrapopliteal, Absorbable |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NXW devices
openFDA lists no recalls for product code NXW.
Frequently asked questions
What is FDA product code NXW?
NXW is the FDA product code for scaffold, infrapopliteal, absorbable. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is NXW?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NXW
- Run a recall and safety report across every NXW manufacturer
- Watch product code NXW 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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