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FDA 510(k)

Gelweave Vascular Grafts

K-Number: K162794 · 2017-06-30

ApplicantVascutek, Ltd.
Decision Date2017-06-30
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gelweave Vascular Grafts is a medical device manufactured by Vascutek, Ltd.. It received FDA 510(k) clearance on 2017-06-30 under approval number K162794. 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 Gelweave Vascular Grafts?

Gelweave Vascular Grafts is a medical device that received FDA 510(k) clearance on 2017-06-30. It is manufactured by Vascutek, Ltd.. The 510(k) number is K162794.

When was Gelweave Vascular Grafts approved by the FDA?

Gelweave Vascular Grafts received FDA 510(k) clearance on 2017-06-30, under approval number K162794.

What company makes Gelweave Vascular Grafts?

Gelweave Vascular Grafts is manufactured by Vascutek, Ltd..

What is the FDA product code for Gelweave Vascular Grafts?

The FDA product code for Gelweave Vascular Grafts is DSY.

Related Clinical Trials

NCT05729620 Evaluation of STARgraft-3 for Hemodialysis ACTIVE_NOT_RECRUITING

Other Devices by Vascutek, Ltd.

K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch K202703Vascutek Gelsoft Plus ERS Vascular Graft K241070Gelsoft™ Plus Vascular Prostheses K241550Gelweave™ Vascular Prostheses PMA P210006Hybrid stent graft, thoracic aortic lesion treatment

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Related Devices (Code: DSY)

K153523FUSION Vascular GraftMaquet Cardiovascular, LLC K172637HeRO GraftMerit Medical Systems, Inc. K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd. K180957exGraft, exGraft Carbon ePTFE Vascular GraftsPeca Labs K183613exGraft, exGraft CarbonPeca Labs K202471exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftPeca Labs

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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