# K142062: Spiral Flow Peripheral Vascular Graft

- Pathway: 510(k) (Special)
- Applicant: Vascular Flow Technologies, Ltd.
- Decided: Nov 20, 2014 after 113 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 5.

## Most influential descendants
- K150389: Spiral Flow Peripheral Vascular Graft (2015), 0 descendants of its own

## Indications for use
The Spiral Flow Peripheral Vascular Grafts are indicated for use as vascular prostheses. The device is intended for use in the bypass or 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. 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/K142062
Methodology: https://510kreport.com/methodology