DEVICE CLASS
Class II
REGULATION
21 CFR 870.1200
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K261455Spectrum Vascular · 510k2026-06-26
K252702Bioptimal International Pte. , Ltd. · 510k2026-05-28
K254278Spectrum Vascular · 510k2026-03-25
K250751Terumo Corporation · 510k2025-07-17
K242966Gentuity, LLC · 510k2025-01-31
K242420Phenox, Ltd. · 510k2024-11-12
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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