FDA 510(k)

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter

Número K: K210647 · 2021-04-30

Data da decisão2021-04-30

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2021-04-30 under 510(k) number K210647. 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 SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K210647.

When did SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter receive FDA 510(k) clearance?

SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210647.

Who is the listed applicant for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

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

What is the FDA product code for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter?

The FDA product code for SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter is DQY.

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Fonte oficial

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