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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K250859
Device Name TransForm McCarthy Mitral Annuloplasty Ring (TF)
Applicant
Genesee Biomedical, Inc.
700 W. Mississippi Ave., Unit D-5
Denver,  CO  80223
Applicant Contact James Cross
Correspondent
Genesee Biomedical, Inc.
700 W. Mississippi Ave., Unit D-5
Denver,  CO  80223
Correspondent Contact James Cross
Regulation Number870.3800
Classification Product Code
KRH  
Subsequent Product Code
DTI  
Date Received03/21/2025
Decision Date 07/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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