FDA 510(k)

Edwards MC3 Tricuspid annuloplasty ring (4900)

Número K: K251982 · 2025-09-23

Data da decisão2025-09-23

Código do produtoKRH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Edwards MC3 Tricuspid annuloplasty ring (4900) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2025-09-23 under 510(k) number K251982. 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 Edwards MC3 Tricuspid annuloplasty ring (4900)?

Edwards MC3 Tricuspid annuloplasty ring (4900) is a medical device that received FDA 510(k) clearance on 2025-09-23. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K251982.

When did Edwards MC3 Tricuspid annuloplasty ring (4900) receive FDA 510(k) clearance?

Edwards MC3 Tricuspid annuloplasty ring (4900) received FDA 510(k) clearance on 2025-09-23, under 510(k) number K251982.

Who is the listed applicant for Edwards MC3 Tricuspid annuloplasty ring (4900)?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edwards MC3 Tricuspid annuloplasty ring (4900)?

The FDA product code for Edwards MC3 Tricuspid annuloplasty ring (4900) is KRH.

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Outros registros que listam Edwards Lifesciences, LLC como candidato(a)

K251326Respiration Rate algorithm K253186HemoSphere Nano Monitor (HSNANO1)K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)K242518Hypertension Prediction Index (HePI) Algorithm K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors K240078Fogarty Thru-Lumen Embolectomy Catheter

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Fonte oficial

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