FDA 510(k)

DuraGraft Vascular Conduit Solution

Número K: K240925 · 2024-05-01

Data da decisão2024-05-01

Código do produtoQEJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DuraGraft Vascular Conduit Solution is the device name listed in this FDA 510(k) record. The listed applicant is Marizyme. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K240925. The device is classified under product code QEJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DuraGraft Vascular Conduit Solution?

DuraGraft Vascular Conduit Solution is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Marizyme. The 510(k) number is K240925.

When did DuraGraft Vascular Conduit Solution receive FDA 510(k) clearance?

DuraGraft Vascular Conduit Solution received FDA 510(k) clearance on 2024-05-01, under 510(k) number K240925.

Who is the listed applicant for DuraGraft Vascular Conduit Solution?

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

What is the FDA product code for DuraGraft Vascular Conduit Solution?

The FDA product code for DuraGraft Vascular Conduit Solution is QEJ.

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