Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007676031

FEI Number

3007676031

Entity Name

Vascular Flow Technologies Ltd

City/State/Country

Dundee Dundee City, GB

Establishment Address

Michelin Scotland Innovation Parc, Fulhame Building, Baldovie Rd, Dundee Dundee City DD4 8UQ, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Vascular Flow Technologies Limited (Owner Number: 10029085)

Owner / Operator Contact Address

Michelin Scotland Innovation Parc, Fulhame Building, Baldovie Rd, Dundee, GB-DND DD4 8UQ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252277

PMA Number

N/A

All Registered Proprietary Names

Spiral Laminar FlowTM Vascular Arteriovenous Graft (AV0645)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2025-12-18

Official Correspondent

Angela Paterson

US Agent Details

Edwin Lindsay Business: RAF Solutions Inc Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

Vascular Flow Technologies Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962639	Impra, Inc.	IMPRA CARBOFLO EPTFE VASCULAR GRAFT	1996-10-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2026	W L Gore & Associates, Inc.	2	GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.

Similar Registrations

Registration Number	Establishment Name	Location
3011175548	Atrium Medical Corporation	Merrimack, NH, US
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1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US
1640201	Intervascular SAS	LA CIOTAT Bouches-du-Rhone, FR
3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007676031. Last updated year: 2026. Please use registration number 3007676031 when referencing this establishment in official correspondence.