Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TransForm McCarthy Mitral Annuloplasty Ring (TF)

K-Number: K250859 · 2025-07-25

ApplicantGenesee Biomedical, Inc.
Decision Date2025-07-25
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TransForm McCarthy Mitral Annuloplasty Ring (TF) is a medical device manufactured by Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2025-07-25 under approval number K250859. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TransForm McCarthy Mitral Annuloplasty Ring (TF)?

TransForm McCarthy Mitral Annuloplasty Ring (TF) is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by Genesee Biomedical, Inc.. The 510(k) number is K250859.

When was TransForm McCarthy Mitral Annuloplasty Ring (TF) approved by the FDA?

TransForm McCarthy Mitral Annuloplasty Ring (TF) received FDA 510(k) clearance on 2025-07-25, under approval number K250859.

What company makes TransForm McCarthy Mitral Annuloplasty Ring (TF)?

TransForm McCarthy Mitral Annuloplasty Ring (TF) is manufactured by Genesee Biomedical, Inc..

What is the FDA product code for TransForm McCarthy Mitral Annuloplasty Ring (TF)?

The FDA product code for TransForm McCarthy Mitral Annuloplasty Ring (TF) is KRH.

Related Clinical Trials

NCT04147884 A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation ACTIVE_NOT_RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT03929913 NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study COMPLETED

Other Devices by Genesee Biomedical, Inc.

K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band K190506NeoForm Annuloplasty Ring K202253TruForm Sievers Annuloplasty Ring K230679WellsForm Tricuspid Annuloplasty Band (WF) K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)

Related Devices (Code: KRH)

K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty BandGenesee Biomedical, Inc. K181132Tri-Ad 2.0 Adams Tricuspid BandMedtronic K180411MEMO 4DSorin Group Italia S.R.L. K192762Physio Flex Annuloplasty RingEdwards Lifesciences, LLC K190506NeoForm Annuloplasty RingGenesee Biomedical, Inc. K202253TruForm Sievers Annuloplasty RingGenesee Biomedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑