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FDA 510(k)

EPTFE RINGED GORE-TEX VASCULAR GRAFT

K-Number: K991602 · 1999-07-09

ApplicantW. L. Gore & Associates, Inc.
Decision Date1999-07-09
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPTFE RINGED GORE-TEX 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 1999-07-09 under 510(k) number K991602. 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 EPTFE RINGED GORE-TEX VASCULAR GRAFT?

EPTFE RINGED GORE-TEX VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1999-07-09. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K991602.

When did EPTFE RINGED GORE-TEX VASCULAR GRAFT receive FDA 510(k) clearance?

EPTFE RINGED GORE-TEX VASCULAR GRAFT received FDA 510(k) clearance on 1999-07-09, under 510(k) number K991602.

Who is the listed applicant for EPTFE RINGED GORE-TEX 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 EPTFE RINGED GORE-TEX VASCULAR GRAFT?

The FDA product code for EPTFE RINGED GORE-TEX 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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