FDA 510(k)

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts

N.º K: K162803 · 2017-07-14

Fecha de decisión2017-07-14

Código de productoDSY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K162803. 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 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Vascutek, Ltd.. The 510(k) number is K162803.

When did Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts receive FDA 510(k) clearance?

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162803.

Who is the listed applicant for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

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

What is the FDA product code for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts?

The FDA product code for Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts is DSY.

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Otros registros que enlistan a Vascutek, Ltd. como solicitante

K241550Gelweave™ Vascular Prostheses K241070Gelsoft™ Plus Vascular Prostheses K202703Vascutek Gelsoft Plus ERS Vascular Graft K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch K162794Gelweave Vascular Grafts

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.

Fuente oficial

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