Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)

FDA 510(k) K252277 · Vascular Flow Technologies Limited

Substantially Equivalent

510(k) numberK252277

Submission

Device name
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
Applicant
Vascular Flow Technologies Limited
Dundee, GB
Received
July 22, 2025
Decision date
October 20, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3450
Specialty
Cardiovascular
Implant
Yes

Other 510(k)s with product code DSY

510(k)DeviceApplicantDecision
K252445Fusion Bioline Vascular GraftDSY · Traditional Maquet Cardiovascular, LLC04/27/2026SE
K241550Gelweave™ Vascular ProsthesesDSY · Traditional Vascutek, Ltd.02/27/2025SE
K241070Gelsoft™ Plus Vascular ProsthesesDSY · Traditional Vascutek, Ltd.11/15/2024SE
K231972Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional Atrium Medical Corporation03/28/2024SE
K240083GORE® PROPATEN® Vascular GraftDSY · Traditional W. L. Gore & Associates, Inc.03/01/2024SE
K233783exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsDSY · Traditional Peca Labs, Inc.01/17/2024SE
K232312GORE® PROPATEN® Vascular GraftDSY · Traditional W. L. Gore & Associates, Inc.01/09/2024SE
K233551GORE® ACUSEAL Vascular GraftDSY · Traditional W. L. Gore & Associates, Inc.12/19/2023SE
K231505GORE® ACUSEAL Vascular GraftDSY · Special W. L. Gore & Associates, Inc.06/23/2023SE
K213845HeRO GraftDSY · Traditional Merit Medical Systems, Inc.08/15/2022SE

More from Merit Medical Systems, Inc.

510(k)DeviceDecision
K150389Spiral Flow Peripheral Vascular GraftDSY · Special 05/06/2015SE
K142062Spiral Flow Peripheral Vascular GraftDSY · Special 11/20/2014SE
K141124Spiral Flow Vascular Arteriovenous GraftDSY · Special 05/30/2014SE

Questions and answers

When was Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) cleared by the FDA?

Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (K252277) received a 510(k) decision of Substantially Equivalent on October 20, 2025, 90 days after the submission was received.

What is the product code of K252277?

The FDA product code is DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.