FDA 510(k)

Brite Tip Radianz Guiding Sheath

Número K: K202167 · 2021-02-26

Data da decisão2021-02-26

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Brite Tip Radianz Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K202167. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Brite Tip Radianz Guiding Sheath?

Brite Tip Radianz Guiding Sheath is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Cordis Corporation. The 510(k) number is K202167.

When did Brite Tip Radianz Guiding Sheath receive FDA 510(k) clearance?

Brite Tip Radianz Guiding Sheath received FDA 510(k) clearance on 2021-02-26, under 510(k) number K202167.

Who is the listed applicant for Brite Tip Radianz Guiding Sheath?

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

What is the FDA product code for Brite Tip Radianz Guiding Sheath?

The FDA product code for Brite Tip Radianz Guiding Sheath is DYB.

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Fonte oficial

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