FDA.report

510(k) K241070

Device
Gelsoft™ Plus Vascular Prostheses
Applicant
Vascutek, Ltd.
510(k) number
K241070
Product code
DSY
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-15
Date received
2024-04-19
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 Renfrewshire 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
05037881166506Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881167053Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881167015Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881166988Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881166964Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881166919Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881166827Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881166773Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881166759Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881166513Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-05-13
05037881166681Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166698Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166674Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166667Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166650Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166643Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166636Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166629Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166612Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166605Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166551Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166544Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166537Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166520Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166063Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166865Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881167039Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881167022Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881167008Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31
05037881166995Gelsoft Plus Vascular ProsthesesVASCUTEK LTD2025-03-31

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
K241550Gelweave™ Vascular ProsthesesVascutek, Ltd.2025-02-27
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