# K094044: Spiral Laminar Flow Vascular Arteriovenous Graft

- Pathway: 510(k) (Traditional)
- Applicant: Tayside Flow Technologies Limited
- Decided: Mar 23, 2010 after 82 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: 3 generations back to K983861 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083169: Eptfe Slftm Spiral Vascular Graft, Tayside Flow Technologies Limited (2009) Summary page 2.
- K051312: Swirlgraft Bypass and Vascular Access Grafts, Veryan Medical Limited (2005) Summary page 2.
- K060741: Swirlgraft Vascular Access Graft, Veryan Medical Limited (2006) Summary page 2.
- K052282: Venaflo II Vascular Graft, Bard Peripheral Vascular, Inc. (2005) Summary page 2.
- K924360: Impra Flex Grafts (Various Product Code Numbers), Impra, Inc. (1992) Summary page 2.
- K043552: Vascutek Ptfe Supported Eptfe Vascular Prostheses, Vascutek, Ltd. (2005) Summary page 2.

## Most influential descendants
- K252277: Spiral Laminar Flow™ Vascular Arteriovenous Graft  (AV0645) (2025), 0 descendants of its own

## Indications for use
The Spiral Laminar FloWTM Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemnodialysis. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.

Source page: https://510kreport.com/device/K094044
Methodology: https://510kreport.com/methodology