FDA 510(k)

5.0 Fr Arndt Endobronchial Blocker Set

Número K: K160542 · 2016-08-02

Data da decisão2016-08-02

Código do produtoCBI

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

5.0 Fr Arndt Endobronchial Blocker Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-08-02 under 510(k) number K160542. 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 5.0 Fr Arndt Endobronchial Blocker Set?

5.0 Fr Arndt Endobronchial Blocker Set is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Cook Incorporated. The 510(k) number is K160542.

When did 5.0 Fr Arndt Endobronchial Blocker Set receive FDA 510(k) clearance?

5.0 Fr Arndt Endobronchial Blocker Set received FDA 510(k) clearance on 2016-08-02, under 510(k) number K160542.

Who is the listed applicant for 5.0 Fr Arndt Endobronchial Blocker Set?

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

What is the FDA product code for 5.0 Fr Arndt Endobronchial Blocker Set?

The FDA product code for 5.0 Fr Arndt Endobronchial Blocker Set is CBI.

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Fonte oficial

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