FDA 510(k)

GORE DrySeal Flex Introducer Sheath

Número K: K160254 · 2016-05-12

Data da decisão2016-05-12

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

GORE DrySeal Flex Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K160254. 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 GORE DrySeal Flex Introducer Sheath?

GORE DrySeal Flex Introducer Sheath is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K160254.

When did GORE DrySeal Flex Introducer Sheath receive FDA 510(k) clearance?

GORE DrySeal Flex Introducer Sheath received FDA 510(k) clearance on 2016-05-12, under 510(k) number K160254.

Who is the listed applicant for GORE DrySeal Flex Introducer Sheath?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE DrySeal Flex Introducer Sheath?

The FDA product code for GORE DrySeal Flex Introducer Sheath is DYB.

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Dispositivos Relacionados (Código: DYB)

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Fonte oficial

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