Cleared Traditional

TransForm McCarthy Mitral Annuloplasty Ring (TF)

K250859 · Genesee Biomedical, Inc. · Cardiovascular
Jul 2025
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K250859 is an FDA 510(k) clearance for the TransForm McCarthy Mitral Annuloplasty Ring (TF), a Ring, Annuloplasty (Class II — Special Controls, product code KRH), submitted by Genesee Biomedical, Inc. (Denver, US). The FDA issued a Cleared decision on July 25, 2025, 126 days after receiving the submission on March 21, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K250859 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2025
Decision Date July 25, 2025
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRH — Ring, Annuloplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3800

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