510(k) K232599

TransForm McCarthy Mitral Annuloplasty Ring (TF) by Genesee Biomedical, Inc. — Product Code KRH

K232599 is an FDA 510(k) premarket notification submitted by Genesee Biomedical, Inc. for the device "TransForm McCarthy Mitral Annuloplasty Ring (TF)". The FDA issued a decision of Substantially Equivalent on April 9, 2024. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Genesee Biomedical, Inc. has at least 10 other 510(k) clearances on record.