DEVICE CLASS
Class II
REGULATION
21 CFR 870.5175
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K261745ElectroWire Medical · 510k2026-06-26
K253799Pressure Products Medical Device Manufacturing, LLC · 510k2026-03-13
K260292Atraverse Medical · 510k2026-02-27
K252419Atraverse Medical, Inc. · 510k2025-08-27
K251007Circa Scientific, Inc. · 510k2025-05-01
K243193Circa Scientific, Inc. · 510k2024-11-26
K242076Baylis Medical Company · 510k2024-11-01
K241414Circa Scientific, Inc. · 510k2024-09-26
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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