FDA 510(k)

Plato MICROCATH 27B Microcatheter

Número K: K170406 · 2017-04-18

Data da decisão2017-04-18

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Plato MICROCATH 27B 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 2017-04-18 under 510(k) number K170406. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Plato MICROCATH 27B Microcatheter?

Plato MICROCATH 27B Microcatheter is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Scientia Vascular, LLC. The 510(k) number is K170406.

When did Plato MICROCATH 27B Microcatheter receive FDA 510(k) clearance?

Plato MICROCATH 27B Microcatheter received FDA 510(k) clearance on 2017-04-18, under 510(k) number K170406.

Who is the listed applicant for Plato MICROCATH 27B 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 MICROCATH 27B Microcatheter?

The FDA product code for Plato MICROCATH 27B Microcatheter is DQO.

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Fonte oficial

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