← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

PNO — Catheter, Percutaneous, Cutting/Scoring

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1250
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K260012Bard Peripheral Vascular, Inc. · 510k2026-02-04
K243944Goodman Co., Ltd. · 510k2025-04-22
K242254Dk Medical Technology Co., Ltd. · 510k2025-04-21
K241478Brosmed Medical Co., Ltd. · 510k2024-10-22

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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