FDA 510(k)

Fusion Bioline Vascular Graft

Número K: K252445 · 2026-04-27

Data da decisão2026-04-27

Código do produtoDSY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fusion Bioline 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 2026-04-27 under 510(k) number K252445. 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 Bioline Vascular Graft?

Fusion Bioline Vascular Graft is a medical device that received FDA 510(k) clearance on 2026-04-27. The listed applicant is Maquet Cardiovascular, LLC. The 510(k) number is K252445.

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

Fusion Bioline Vascular Graft received FDA 510(k) clearance on 2026-04-27, under 510(k) number K252445.

Who is the listed applicant for Fusion Bioline 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 Bioline Vascular Graft?

The FDA product code for Fusion Bioline Vascular Graft is DSY.

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

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 K153194VASOVIEW HemoPro Endoscopic Vessel Harvesting System

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: DSY)

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.K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc.

Fonte oficial

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