FDA.report

510(k) K252277

Device
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
Applicant
Vascular Flow Technologies Limited
510(k) number
K252277
Product code
DSY
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-20
Date received
2025-07-22
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
Angela Paterson
Address
Prospect Business Centre Gemini Crescent Dundee GB DD2 1TY DD2 1TY

FDA Registration Numbers

Source Documents

510(k) summary PDF

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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