FDA 510(k)

Gelsoft Plus Vascular Prostheses

K-Number: K241070 · 2024-11-15

Decision Date2024-11-15

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Gelsoft Plus Vascular Prostheses is a medical device manufactured by Vascutek, Ltd.. It received FDA 510(k) clearance on 2024-11-15 under approval number K241070. 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 Gelsoft Plus Vascular Prostheses?

Gelsoft Plus Vascular Prostheses is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Vascutek, Ltd.. The 510(k) number is K241070.

When was Gelsoft Plus Vascular Prostheses approved by the FDA?

Gelsoft Plus Vascular Prostheses received FDA 510(k) clearance on 2024-11-15, under approval number K241070.

What company makes Gelsoft Plus Vascular Prostheses?

Gelsoft Plus Vascular Prostheses is manufactured by Vascutek, Ltd..

What is the FDA product code for Gelsoft Plus Vascular Prostheses?

The FDA product code for Gelsoft Plus Vascular Prostheses is DSY.

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 K202703Vascutek Gelsoft Plus ERS Vascular Graft 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.