FDA 510(k)

Fusion Bioline Vascular Graft

N.º K: K252445 · 2026-04-27

Fecha de decisión2026-04-27

Código de productoDSY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Maquet Cardiovascular, LLC como solicitante

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)K191930Endoscopio de Longitud Extendida 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 los 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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.