# K092509: Edwards Lifesciences Venous Return Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 8, 2009 after 52 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Edwards Lifesciences Venous Cannula: named in the summary without a submission number

## Most influential descendants
- K120072: Venous Drainage Cannula with Duraflo Coating (2012), 0 descendants of its own

## Indications for use
Dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of < 6 hours. They are also indicated for coronary bypass procedures where single tube venous drainage from the right atrium only is ordinarily contraindicated because of diminished caval return due to intra-operative manipulation of the heart. Venous return cannulae in sizes 6Fr to 18Fr can be used in pediatric patients. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired.

Source page: https://510kreport.com/device/K092509
Methodology: https://510kreport.com/methodology