← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MCW — Catheter, Peripheral, Atherectomy

DEVICE CLASS
Class II
REGULATION
21 CFR 870.4875
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K260244Eximo Medical · 510k2026-04-10
K250723Cardio Flow Inc., · 510k2025-04-25
K250385Spectranetics · 510k2025-03-13
K242757Bard Peripheral Vascular, Inc. · 510k2025-01-30
K242947Cardio Flow Inc., · 510k2024-11-05

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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