DEVICE CLASS
Class II
REGULATION
21 CFR 870.4450
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
K260105Edwards Lifesciences · 510k2026-06-05
K252772Tz Medical, Inc. · 510k2026-05-22
K254060TW Medical · 510k2026-04-03
K243627Arc Trauma, LLC · 510k2025-12-31
K253070Medline Industries, LP · 510k2025-11-20
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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