FDA product code NWX: Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

NWX is the FDA product code for catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring. It is a Class III device, reviewed by the Cardiovascular panel. Devices under NWX reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 3 recalls for NWX devices.

Definition

To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.

Classification

Recalls for NWX devices

3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-07.

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

Frequently asked questions

What is FDA product code NWX?

NWX is the FDA product code for catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring. It is a Class III device, reviewed by the Cardiovascular panel.

What device class is NWX?

Class III. Typical premarket route: PMA.

Have NWX devices been recalled?

Yes: 3 product recalls across 3 recall events; the most recent began 2018-12-07.

Next steps

• Run an FDA pathway report with predicate devices for product code NWX
• Run a recall and safety report across every NWX manufacturer
• Watch product code NWX 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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