FDA 510(k)

Plato 17 Microcatheter

Número K: K210601 · 2021-04-28

Data da decisão2021-04-28

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Plato 17 Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Scientia Vascular, LLC. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K210601. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Plato 17 Microcatheter?

Plato 17 Microcatheter is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K210601.

When did Plato 17 Microcatheter receive FDA 510(k) clearance?

Plato 17 Microcatheter received FDA 510(k) clearance on 2021-04-28, under 510(k) number K210601.

Who is the listed applicant for Plato 17 Microcatheter?

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

What is the FDA product code for Plato 17 Microcatheter?

The FDA product code for Plato 17 Microcatheter is DQY.

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Fonte oficial

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