FDA 510(k)

Fogarty Venous Thrombectomy Catheters

Número K: K233819 · 2024-05-22

Data da decisão2024-05-22

Código do produtoDXE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fogarty Venous Thrombectomy Catheters 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 2024-05-22 under 510(k) number K233819. 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 Venous Thrombectomy Catheters?

Fogarty Venous Thrombectomy Catheters is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K233819.

When did Fogarty Venous Thrombectomy Catheters receive FDA 510(k) clearance?

Fogarty Venous Thrombectomy Catheters received FDA 510(k) clearance on 2024-05-22, under 510(k) number K233819.

Who is the listed applicant for Fogarty Venous Thrombectomy Catheters?

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 Fogarty Venous Thrombectomy Catheters?

The FDA product code for Fogarty Venous Thrombectomy Catheters is DXE.

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Dispositivos Relacionados (Código: DXE)

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Fonte oficial

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