← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KRD — Device, Vascular, For Promoting Embolization

DEVICE CLASS
Class II
REGULATION
21 CFR 870.3300
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
16
510(K)/PMA CLEARANCES
510k: 16
0
RECALL ENTRIES

Recent clearances

K261866Medtronic, Inc. · 510k2026-06-24
K260635Nuvascular, Inc. · 510k2026-06-12
K260508Okami Medical, Inc. · 510k2026-04-10
K253511Medtronic, Inc. · 510k2026-01-14
K253677Instylla, Inc. · 510k2025-12-15
K253376Boston Scientific Corporation · 510k2025-10-30
K250209Canyon Medical, Inc. · 510k2025-09-23
K250133Nuvascular, Inc. · 510k2025-07-09

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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