Cleared Traditional

Spiral Laminar Flow? Vascular Arteriovenous Graft (AV0645)

K252277 · Vascular Flow Technologies Limited · Cardiovascular

Oct 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K252277 is an FDA 510(k) clearance for the Spiral Laminar Flow? Vascular Arteriovenous Graft (AV0645), a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascular Flow Technologies Limited (Dundee, GB). The FDA issued a Cleared decision on October 20, 2025, 90 days after receiving the submission on July 22, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number	K252277 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2025
Decision Date	October 20, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF