FDA.reportPublic FDA data

510(k) K231972

Device
Advanta VXT Vascular Graft, Flixene Vascular Graft
Applicant
Atrium Medical Corporation
510(k) number
K231972
Product code
DSY
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-28
Date received
2023-07-03
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
Hannah Scribner
Address
40 Continental Blvd. Merrimack NH US 03054 03054

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
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
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