# K081560: Vascutek Cannula Graft, Model CGS2008S

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Feb 10, 2009 after 252 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- 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 K934127 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934127: Sarns Low Jetting Aortic Arch Cannula, 3M Health Care, Sarns (1994) Summary page 1.
- K041528: Modification to Eptfe Graft, Vascutek, Ltd. (2004) Summary page 1.

## Most influential descendants
- K203057: Quantum Perfusion Arterial Cannula Graft (2021), 0 descendants of its own

## Indications for use
This device is intended to be used in axillary arterial perfusion during cardiopulmonary bypass procedures. These devices are indicated for up to 6 hours of use.

Source page: https://510kreport.com/device/K081560
Methodology: https://510kreport.com/methodology