# K252277: Spiral Laminar Flow™ Vascular Arteriovenous Graft  (AV0645)

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Flow Technologies Limited
- Decided: Oct 20, 2025 after 90 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983861 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141124: Spiral Flow Vascular Arteriovenous Graft, Vascular Flow Technologies, Ltd. (2014) Summary page 6.
- K094044: Spiral Laminar Flow Vascular Arteriovenous Graft, Tayside Flow Technologies Limited (2010) Summary page 6.

## Indications for use
The Spiral Laminar Flow Vascular Arteriovenous Graft is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis.

Source page: https://510kreport.com/device/K252277
Methodology: https://510kreport.com/methodology