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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 the device name listed in this FDA 510(k) record. The listed applicant is Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) 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. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K250859.

When did TransForm McCarthy Mitral Annuloplasty Ring (TF) receive FDA 510(k) clearance?

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

Who is the listed applicant for TransForm McCarthy Mitral Annuloplasty Ring (TF)?

The FDA 510(k) record lists Genesee Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04147884A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT04761120Annuloplasty Rings and Band Post-Market Clinical Follow-Up StudyRECRUITING

Other records listing Genesee Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)K230679WellsForm Tricuspid Annuloplasty Band (WF)K202253TruForm Sievers Annuloplasty RingK190506NeoForm Annuloplasty RingK161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

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Related Devices (Code: KRH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.K253232Seguin Annuloplasty RingABBOTT MEDICALK251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLCK251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLCK232599TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee 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.

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