FDA 510(k)

RadialSeal Introducer Kit

Número K: K181855 · 2018-07-26

Data da decisão2018-07-26

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

RadialSeal Introducer Kit is the device name listed in this FDA 510(k) record. The listed applicant is Great Batch Medical. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181855. 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 RadialSeal Introducer Kit?

RadialSeal Introducer Kit is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Great Batch Medical. The 510(k) number is K181855.

When did RadialSeal Introducer Kit receive FDA 510(k) clearance?

RadialSeal Introducer Kit received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181855.

Who is the listed applicant for RadialSeal Introducer Kit?

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

What is the FDA product code for RadialSeal Introducer Kit?

The FDA product code for RadialSeal Introducer Kit is DYB.

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Fonte oficial

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