← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

NWX — Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

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.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
pma: 4
0
RECALL ENTRIES

Recent clearances

P950020Boston Scientific Corp · pma2026-01-27
P200041OrbusNeich Medical (Shenzhen) Co., Ltd. · pma2025-10-29
P050018Spectranetics Corp. · pma2025-04-04
P230026Goodman Co., Ltd. · pma2024-08-02

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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