DEVICE CLASS
Class II
REGULATION
21 CFR 870.2770
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES
Recent clearances
K250634Fresenius Medical Care Renal Therapies Group, LLC · 510k2025-11-24
K243727Mode Sensors AS · 510k2025-10-16
K250922Cardioset Medical , Ltd. · 510k2025-09-09
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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