FDA 510(k)

Fogarty Fortis Arterial Embolectomy Catheter

Número K: K241330 · 2024-07-02

Data da decisão2024-07-02

Código do produtoDXE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fogarty Fortis Arterial Embolectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2024-07-02 under 510(k) number K241330. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fogarty Fortis Arterial Embolectomy Catheter?

Fogarty Fortis Arterial Embolectomy Catheter is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Edwards Lifesciences. The 510(k) number is K241330.

When did Fogarty Fortis Arterial Embolectomy Catheter receive FDA 510(k) clearance?

Fogarty Fortis Arterial Embolectomy Catheter received FDA 510(k) clearance on 2024-07-02, under 510(k) number K241330.

Who is the listed applicant for Fogarty Fortis Arterial Embolectomy Catheter?

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

What is the FDA product code for Fogarty Fortis Arterial Embolectomy Catheter?

The FDA product code for Fogarty Fortis Arterial Embolectomy Catheter is DXE.

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Outros registros que listam Edwards Lifesciences como candidato(a)

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Dispositivos Relacionados (Código: DXE)

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Fonte oficial

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