FDA 510(k)

Vascutek Gelsoft Plus ERS Vascular Graft

K-Number: K202703 · 2021-04-06

Decision Date2021-04-06

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Vascutek Gelsoft Plus ERS Vascular Graft is a medical device manufactured by Vascutek, Ltd.. It received FDA 510(k) clearance on 2021-04-06 under approval number K202703. 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 Vascutek Gelsoft Plus ERS Vascular Graft?

Vascutek Gelsoft Plus ERS Vascular Graft is a medical device that received FDA 510(k) clearance on 2021-04-06. It is manufactured by Vascutek, Ltd.. The 510(k) number is K202703.

When was Vascutek Gelsoft Plus ERS Vascular Graft approved by the FDA?

Vascutek Gelsoft Plus ERS Vascular Graft received FDA 510(k) clearance on 2021-04-06, under approval number K202703.

What company makes Vascutek Gelsoft Plus ERS Vascular Graft?

Vascutek Gelsoft Plus ERS Vascular Graft is manufactured by Vascutek, Ltd..

What is the FDA product code for Vascutek Gelsoft Plus ERS Vascular Graft?

The FDA product code for Vascutek Gelsoft Plus ERS Vascular Graft is DSY.

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Other Devices by Vascutek, Ltd.

K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts K162794Gelweave Vascular Grafts K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch 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. K162794Gelweave Vascular GraftsVascutek, Ltd. K180957exGraft, exGraft Carbon ePTFE Vascular GraftsPeca Labs K183613exGraft, exGraft CarbonPeca 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.