FDA 510(k)

TransForm McCarthy Mitral Annuloplasty Ring (TF)

Número K: K232599 · 2024-04-09

Data da decisão2024-04-09

Código do produtoKRH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2024-04-09 under 510(k) number K232599. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2024-04-09. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K232599.

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 2024-04-09, under 510(k) number K232599.

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.

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Outros registros que listam Genesee Biomedical, Inc. como candidato(a)

K252917ATLAAS (Sistema de Apendice Atrial Esquerdo Atraumático) (AD)K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)K230679WellsForm Tricuspid Annuloplasty Band (WF)K202253TruForm Sievers Annuloplasty Ring K190506NeoForm Annuloplasty Ring K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

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Dispositivos Relacionados (Código: KRH)

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Fonte oficial

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