FDA 510(k)

Superpipe Angiographic Catheter

Número K: K193647 · 2020-07-29

RequerenteSuzhou Hengrui Disheng Medical Co., Ltd.

Data da decisão2020-07-29

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Superpipe Angiographic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-07-29 under 510(k) number K193647. 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 Superpipe Angiographic Catheter?

Superpipe Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Suzhou Hengrui Disheng Medical Co., Ltd.. The 510(k) number is K193647.

When did Superpipe Angiographic Catheter receive FDA 510(k) clearance?

Superpipe Angiographic Catheter received FDA 510(k) clearance on 2020-07-29, under 510(k) number K193647.

Who is the listed applicant for Superpipe Angiographic Catheter?

The FDA 510(k) record lists Suzhou Hengrui Disheng Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Superpipe Angiographic Catheter?

The FDA product code for Superpipe Angiographic Catheter is DQO.

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Fonte oficial

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