# K983270: Voyager Quad Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Cardiothoracic Systems, Inc.
- Decided: Jul 28, 1999 after 314 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cardiopulmonary bypass cannulae manufactured by Medtronic: named in the summary without a submission number
- (no number) Cardiopulmonary bypass cannulae manufactured by Sarns: named in the summary without a submission number
- (no number) Cannulae manufactured by Research Medical, Inc. (RMI): named in the summary without a submission number
- (no number) DLP (Medtronic) cannulae: named in the summary without a submission number

## Indications for use
The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The cannula functions to occlude the ascending aorta when the balloon is inflated. The main lumen of the cannula provides delivery of arterial perfusion. The side lumen allows delivery of cardioplegia to arrest the heart and venting of fluid from the aortic root during cardiac surgery.

Source page: https://510kreport.com/device/K983270
Methodology: https://510kreport.com/methodology