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FDA 510(k)

GORE ACUSEAL VASCULAR GRAFT

K-Number: K130215 · 2013-04-09

ApplicantW. L. Gore & Associates, Inc.
Decision Date2013-04-09
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GORE ACUSEAL VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2013-04-09 under 510(k) number K130215. 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 ACUSEAL VASCULAR GRAFT?

GORE ACUSEAL VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2013-04-09. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K130215.

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

GORE ACUSEAL VASCULAR GRAFT received FDA 510(k) clearance on 2013-04-09, under 510(k) number K130215.

Who is the listed applicant for GORE ACUSEAL VASCULAR GRAFT?

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

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

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

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Other records listing W. L. Gore & Associates, Inc. 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.

K250410GORE® Tri-Lobe Balloon CatheterK240083GORE® PROPATEN® Vascular GraftK232312GORE® PROPATEN® Vascular GraftK233551GORE® ACUSEAL Vascular GraftK231505GORE® ACUSEAL Vascular GraftK222919GORE® ENFORM Biomaterial

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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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