# K960706: Vascutek Vascusoft Plus Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Carbomedics, Inc.
- Decided: Apr 25, 1996 after 64 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: 1 generation back to K910866 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910866: Vascusoft (VP1200K) Knitted Vascular Prosthesis, Vascutek, Ltd. (1991) Summary page 1.

## Indications for use
The Vascusoft™ Plus Vascular Graft is indicated for systemic vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Coronary vascular repair and blood access fistula (e.g. hemodialysis) are contraindicated with this device.

Source page: https://510kreport.com/device/K960706
Methodology: https://510kreport.com/methodology