FDA.report

510(k) K241550

Device
Gelweave™ Vascular Prostheses
Applicant
Vascutek, Ltd.
510(k) number
K241550
Product code
DSY
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-27
Date received
2024-05-31
Regulation
870.3450
Classification name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ryan King
Address
Newmains Ave. Inchinnan GB PA49RR PA49RR

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
05037881175393Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881176406Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175027Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174761Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174624Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881114040Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174655Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174990Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174860Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174785Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881176390Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175324Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175133Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175096Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175249Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881176383Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881176338Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175355Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174952Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174631Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174594Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174914Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881176352Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175164Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175119Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881176321Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174808Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881174648Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175386Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881175218Gelweave Vascular ProsthesesVASCUTEK LTD2025-05-13

Other 510(k) Records For Product Code DSY

510(k)DeviceApplicantDecision date
K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC2026-04-27
K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited2025-10-20
K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.2024-11-15
K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation2024-03-28
K240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.2024-03-01
K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsPeca Labs, Inc.2024-01-17
K232312GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.2024-01-09
K233551GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.2023-12-19
K231505GORE® ACUSEAL Vascular GraftW. L. Gore & Associates, Inc.2023-06-23
K213845HeRO GraftMerit Medical Systems, Inc.2022-08-15
K221628exGraft, exGraft CarbonPeca Labs2022-08-04
K203724HeRO Graft, HeRO AdapterMerit Medical Systems, Inc.2021-05-25
K202703Vascutek Gelsoft Plus ERS Vascular GraftVascutek, Ltd.2021-04-06
K202471exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular GraftPeca Labs2020-12-11
K183613exGraft, exGraft CarbonPeca Labs2019-04-22