← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KRH — Ring, Annuloplasty

DEVICE CLASS
Class II
REGULATION
21 CFR 870.3800
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

K261707Corcym S.r.l. · 510k2026-06-18
K260498Corcym S.r.l. · 510k2026-04-14
K253232ABBOTT MEDICAL · 510k2025-10-29
K251982Edwards Lifesciences, LLC · 510k2025-09-23
K251688Edwards Lifesciences, LLC · 510k2025-09-17
K250859Genesee Biomedical, Inc. · 510k2025-07-25

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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