FDA 510(k)

Turbo-Flo PICC Sets

Número K: K161496 · 2016-10-07

Data da decisão2016-10-07

Código do produtoLJS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Turbo-Flo PICC Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-10-07 under 510(k) number K161496. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Turbo-Flo PICC Sets?

Turbo-Flo PICC Sets is a medical device that received FDA 510(k) clearance on 2016-10-07. The listed applicant is Cook Incorporated. The 510(k) number is K161496.

When did Turbo-Flo PICC Sets receive FDA 510(k) clearance?

Turbo-Flo PICC Sets received FDA 510(k) clearance on 2016-10-07, under 510(k) number K161496.

Who is the listed applicant for Turbo-Flo PICC Sets?

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 Turbo-Flo PICC Sets?

The FDA product code for Turbo-Flo PICC Sets is LJS.

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