FDA.reportPublic FDA data

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
No

Applicant Contact#

Contact
Ryan King
Address
Newmains Ave. Inchinnan Renfrewshire GB PA49RR PA49RR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC2026-04-27
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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