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FDA 510(k)

GORE HYBRID VASCULAR GRAFT

K-Number: K093934 · 2010-03-17

ApplicantW.L. Gore & Associates
Decision Date2010-03-17
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE HYBRID VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is W.L. Gore & Associates. It received FDA 510(k) clearance on 2010-03-17 under 510(k) number K093934. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GORE HYBRID VASCULAR GRAFT?

GORE HYBRID VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2010-03-17. The listed applicant is W.L. Gore & Associates. The 510(k) number is K093934.

When did GORE HYBRID VASCULAR GRAFT receive FDA 510(k) clearance?

GORE HYBRID VASCULAR GRAFT received FDA 510(k) clearance on 2010-03-17, under 510(k) number K093934.

Who is the listed applicant for GORE HYBRID VASCULAR GRAFT?

The FDA 510(k) record lists W.L. Gore & Associates as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE HYBRID VASCULAR GRAFT?

The FDA product code for GORE HYBRID VASCULAR GRAFT is DSY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing W.L. Gore & Associates as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120480GORE(R) EMBOLIC FILTERK053202GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

Related Devices (Code: DSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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