FDA 510(k)

InTRAkit

Número K: K162097 · 2016-11-17

Data da decisão2016-11-17

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

InTRAkit is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162097. 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 InTRAkit?

InTRAkit is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Medtronic Vascular. The 510(k) number is K162097.

When did InTRAkit receive FDA 510(k) clearance?

InTRAkit received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162097.

Who is the listed applicant for InTRAkit?

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

What is the FDA product code for InTRAkit?

The FDA product code for InTRAkit is DYB.

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Fonte oficial

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