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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2025-02-27 under 510(k) 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. The listed applicant is Vascutek, Ltd.. The 510(k) number is K241550.

When did Gelweave™ Vascular Prostheses receive FDA 510(k) clearance?

Gelweave™ Vascular Prostheses received FDA 510(k) clearance on 2025-02-27, under 510(k) number K241550.

Who is the listed applicant for Gelweave™ Vascular Prostheses?

The FDA 510(k) record lists Vascutek, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gelweave™ Vascular Prostheses?

The FDA product code for Gelweave™ Vascular Prostheses 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.

NCT04545502PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular PatchesRECRUITINGNCT07078383A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the AortaRECRUITING

Other records listing Vascutek, Ltd. 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.

PMA P210006Hybrid stent graft, thoracic aortic lesion treatmentK241070Gelsoft™ Plus Vascular ProsthesesK202703Vascutek Gelsoft Plus ERS Vascular GraftK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchK162803Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsK162794Gelweave Vascular Grafts

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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 LimitedK241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc.

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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