Gelweave Vascular Prostheses
K-Number: K241550 · 2025-02-27
ApplicantVascutek, Ltd.
Decision Date2025-02-27
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Gelweave Vascular Prostheses is a medical device manufactured by Vascutek, Ltd.. It received FDA 510(k) clearance on 2025-02-27 under approval number K241550. 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 Prostheses?
Gelweave Vascular Prostheses is a medical device that received FDA 510(k) clearance on 2025-02-27. It is manufactured by Vascutek, Ltd.. The 510(k) number is K241550.
When was Gelweave Vascular Prostheses approved by the FDA?
Gelweave Vascular Prostheses received FDA 510(k) clearance on 2025-02-27, under approval number K241550.
What company makes Gelweave Vascular Prostheses?
Gelweave Vascular Prostheses is manufactured by Vascutek, Ltd..
What is the FDA product code for Gelweave Vascular Prostheses?
The FDA product code for Gelweave Vascular Prostheses is DSY.
Other Devices by Vascutek, Ltd.
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K162794Gelweave Vascular Grafts
K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K202703Vascutek Gelsoft Plus ERS Vascular Graft
K241070Gelsoft Plus Vascular Prostheses
PMA P210006Hybrid stent graft, thoracic aortic lesion treatment
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K162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd.
K162794Gelweave Vascular GraftsVascutek, Ltd.
K180957exGraft, exGraft Carbon ePTFE Vascular GraftsPeca Labs
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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.