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510(k) K252277

Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) by Vascular Flow Technologies Limited — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2025
Date Received
July 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

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