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FDA 510(k)

DIASTAT VASCULAR ACCESS GRAFT

K-Number: K940062 · 1994-05-02

ApplicantW. L. Gore & Associates, Inc.
Decision Date1994-05-02
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking & PMS

Device Summary

DIASTAT VASCULAR ACCESS 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 1994-05-02 under 510(k) number K940062. 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 DIASTAT VASCULAR ACCESS GRAFT?

DIASTAT VASCULAR ACCESS GRAFT is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K940062.

When did DIASTAT VASCULAR ACCESS GRAFT receive FDA 510(k) clearance?

DIASTAT VASCULAR ACCESS GRAFT received FDA 510(k) clearance on 1994-05-02, under 510(k) number K940062.

Who is the listed applicant for DIASTAT VASCULAR ACCESS 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 DIASTAT VASCULAR ACCESS GRAFT?

The FDA product code for DIASTAT VASCULAR ACCESS 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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