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FDA 510(k)

VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT

K-Number: K880041 · 1988-06-10

ApplicantD-R Medical Systems, Inc.
Decision Date1988-06-10
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is D-R Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-06-10 under 510(k) number K880041. 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 VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT?

VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is D-R Medical Systems, Inc.. The 510(k) number is K880041.

When did VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT receive FDA 510(k) clearance?

VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT received FDA 510(k) clearance on 1988-06-10, under 510(k) number K880041.

Who is the listed applicant for VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT?

The FDA 510(k) record lists D-R Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT?

The FDA product code for VELEX WOVEN DACRON LOW PORSITY 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 D-R Medical Systems, 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.

K890597EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTSK880040VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT

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

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

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