DEVICE CLASS
Class II
REGULATION
21 CFR 870.4350
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
K253838Lifemotion Medical Technology Co., Ltd. · 510k2026-03-16
K240934Spectrum Medical S.R.L. · 510k2026-03-12
K250821Eurosets S.R.L · 510k2025-12-12
K242503Eurosets S.R.L · 510k2025-11-24
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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