FDA 510(k)

Sheridan Endobronchial Tubes

Número K: K180253 · 2018-11-02

Data da decisão2018-11-02

Código do produtoCBI

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sheridan Endobronchial Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K180253. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sheridan Endobronchial Tubes?

Sheridan Endobronchial Tubes is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Teleflex Medical. The 510(k) number is K180253.

When did Sheridan Endobronchial Tubes receive FDA 510(k) clearance?

Sheridan Endobronchial Tubes received FDA 510(k) clearance on 2018-11-02, under 510(k) number K180253.

Who is the listed applicant for Sheridan Endobronchial Tubes?

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

What is the FDA product code for Sheridan Endobronchial Tubes?

The FDA product code for Sheridan Endobronchial Tubes is CBI.

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Fonte oficial

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