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FDA 510(k)

VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT

K-Number: K880040 · 1988-06-09

ApplicantD-R Medical Systems, Inc.
Decision Date1988-06-09
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VELEX WOVEN EXTERNAL VELOUR DACRON 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 1988-06-09 under 510(k) number K880040. 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 EXTERNAL VELOUR DACRON GRAFT?

VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT is a medical device that received FDA 510(k) clearance on 1988-06-09. The listed applicant is D-R Medical Systems, Inc.. The 510(k) number is K880040.

When did VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT receive FDA 510(k) clearance?

VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT received FDA 510(k) clearance on 1988-06-09, under 510(k) number K880040.

Who is the listed applicant for VELEX WOVEN EXTERNAL VELOUR DACRON 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 EXTERNAL VELOUR DACRON GRAFT?

The FDA product code for VELEX WOVEN EXTERNAL VELOUR DACRON 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 GRAFTSK880041VELEX WOVEN DACRON LOW PORSITY VASCULAR 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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