# K083169: Eptfe Slftm Spiral Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Tayside Flow Technologies Limited
- Decided: Mar 30, 2009 after 154 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: 2 generations back to K983861 (1998). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051312: Swirlgraft Bypass and Vascular Access Grafts, Veryan Medical Limited (2005) Summary page 2.
- K983861: Distaflo Bypass Graft, Impra, Inc. (1998) Summary page 2.
- K050049: Dynaflo Bypass Graft, Bard Peripheral Vascular, Inc. (2005) Summary page 2.
- K043552: Vascutek Ptfe Supported Eptfe Vascular Prostheses, Vascutek, Ltd. (2005) Summary page 2.

## Most influential descendants
- K142062: Spiral Flow Peripheral Vascular Graft (2014), 1 descendant of its own
- K094044: Spiral Laminar Flow Vascular Arteriovenous Graft (2010), 1 descendant of its own
- K252277: Spiral Laminar Flow™ Vascular Arteriovenous Graft  (AV0645) (2025), 0 descendants of its own
- K150389: Spiral Flow Peripheral Vascular Graft (2015), 0 descendants of its own

## Indications for use
The ePTFE SLF™ Spiral Vascular Graft is indicated for ruse as a vascular prosthesis. It is intended for use in the bypass of reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.

Source page: https://510kreport.com/device/K083169
Methodology: https://510kreport.com/methodology