FDA 510(k)

Gianturco-Roehm Bird’s Nest Vena Cava Filter

Número K: K161218 · 2016-07-22

Data da decisão2016-07-22

Código do produtoDTK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Gianturco-Roehm Bird’s Nest Vena Cava Filter is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K161218. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Gianturco-Roehm Bird’s Nest Vena Cava Filter?

Gianturco-Roehm Bird’s Nest Vena Cava Filter is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is Cook Incorporated. The 510(k) number is K161218.

When did Gianturco-Roehm Bird’s Nest Vena Cava Filter receive FDA 510(k) clearance?

Gianturco-Roehm Bird’s Nest Vena Cava Filter received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161218.

Who is the listed applicant for Gianturco-Roehm Bird’s Nest Vena Cava Filter?

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 Gianturco-Roehm Bird’s Nest Vena Cava Filter?

The FDA product code for Gianturco-Roehm Bird’s Nest Vena Cava Filter is DTK.

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