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Gore Hybrid Vascular Graft

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093934

by W.L. Gore & Associates

Identifiers

510(k) Number
K093934 FDA 510(k)
FDA Product Code
DSY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3450 FDA 510(k)
Regulation Number
870.3450 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Gore Hybrid Vascular Graft is a surgically implantable ePTFE vascular prosthesis with a section reinforced with nitinol. It is intended for use as a blood conduit for a permanent replacement of damaged or diseased vessels and for dialysis access.

The device is supplied by W.L. Gore & Associates and is available in various sizes. It is a Class II device with FDA 510(k) clearance under product code DSY, regulation number 870.3450, and is intended for cardiovascular use.

Frequently asked questions

What is the GORE HYBRID VASCULAR GRAFT used for?

The GORE HYBRID VASCULAR GRAFT is a surgically implantable device intended for use as a blood conduit for permanent replacement of damaged or diseased vessels and for dialysis access. It combines ePTFE with a nitinol reinforced section.

How is the GORE HYBRID VASCULAR GRAFT supplied?

The device is supplied by W.L. Gore & Associates and is available in various sizes to accommodate different clinical needs. It is a Class II device with FDA 510(k) clearance under product code DSY.

What is the regulatory status of the GORE HYBRID VASCULAR GRAFT?

The GORE HYBRID VASCULAR GRAFT has FDA 510(k) clearance under product code DSY, regulation number 870.3450. It is classified as a Class II device and is intended for cardiovascular use.

Is the GORE HYBRID VASCULAR GRAFT reusable or single-use?

The device information does not specify whether the GORE HYBRID VASCULAR GRAFT is designed for single-use or multiple uses. Clinicians should refer to the specific instructions for use provided by the manufacturer for proper handling and sterilization protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Over-the-balloon placement of the Gore Hybrid Vascular Graft in ..., GORE Hybrid Vascular Graft - mddionline.com, GOREWEAR online kaufen - Die beste Auswahl | BIKE24, Over-the-balloon placement of the Gore Hybrid Vascular Graft in ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
W.L. Gore & Associates

Sources (1)

  • FDA 510(k) K093934 24 fields · synced Sep 27, 2026