FDA 510(k)

FUSION Vascular Graft

Número K: K153523 · 2016-02-16

Data da decisão2016-02-16

Código do produtoDSY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

FUSION Vascular Graft is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153523. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FUSION Vascular Graft?

FUSION Vascular Graft is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Maquet Cardiovascular, LLC. The 510(k) number is K153523.

When did FUSION Vascular Graft receive FDA 510(k) clearance?

FUSION Vascular Graft received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153523.

Who is the listed applicant for FUSION Vascular Graft?

The FDA 510(k) record lists Maquet Cardiovascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUSION Vascular Graft?

The FDA product code for FUSION Vascular Graft is DSY.

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Outros registros que listam Maquet Cardiovascular, LLC como candidato(a)

K252445Fusion Bioline Vascular Graft K251238Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)K243918Vasoview Hemopro 3 Power Supply K233879Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020)K191930Endoscópio de Comprimento Extendido de 7 mm K191947VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: DSY)

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited K241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Graft Vascular FlixeneAtrium Medical Corporation K240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.

Fonte oficial

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