DEVICE CLASS
Class II
REGULATION
21 CFR 870.2100
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
K260700BlueDop Medical, Ltd. · 510k2026-07-08
K252810Flosonics Medical · 510k2026-04-24
K251904Remington Medical, Inc. · 510k2025-11-20
K251114Flosonics Medical · 510k2025-06-20
K243852Elfi-Tech , Ltd. · 510k2025-04-14
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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