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FDA 510(k)

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

K-Number: K941981 · 1994-07-20

ApplicantW. L. Gore & Associates, Inc.
Decision Date1994-07-20
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking & PMS

Device Summary

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED 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 1994-07-20 under 510(k) number K941981. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking & PMS.

Frequently Asked Questions

What is the AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED?

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED is a medical device that received FDA 510(k) clearance on 1994-07-20. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K941981.

When did AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED receive FDA 510(k) clearance?

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED received FDA 510(k) clearance on 1994-07-20, under 510(k) number K941981.

Who is the listed applicant for AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED?

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 AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED?

The FDA product code for AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED 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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