DEVICE CLASS
Class II
REGULATION
21 CFR 870.3680
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
K242863Bioptimal International Pte. , Ltd. · 510k2025-06-15
K251186C.R. Bard, Inc. · 510k2025-05-15
K241334C.R. Bard, Inc. · 510k2025-01-31
K241199Shenzhen Launch Electrical Co., Ltd. · 510k2025-01-23
K242705Medtronic, Inc. · 510k2025-01-17
Related on SPEQ
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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