FDA.report

510(k) K240083

Device
GORE® PROPATEN® Vascular Graft
Applicant
W. L. Gore & Associates, Inc.
510(k) number
K240083
Product code
DSY
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-01
Date received
2024-01-11
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

Related Records

Applicant Contact

Contact
Christine Snyder
Address
1505 N Fourth St. Flagstaff AZ US 86004 86004

FDA Registration Numbers

Source Documents

510(k) summary PDF

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
K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.2024-11-15
K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation2024-03-28
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