510(k) K250859

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

K250859 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 July 25, 2025. 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.