Cleared Traditional

TransForm McCarthy Mitral Annuloplasty Ring (TF)

K232599 · Genesee Biomedical, Inc. · Cardiovascular
Apr 2024
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K232599 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 April 9, 2024, 225 days after receiving the submission on August 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number K232599 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2023
Decision Date April 09, 2024
Days to Decision 225 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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