# K120072: Venous Drainage Cannula with Duraflo Coating

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: May 8, 2012 after 119 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831769 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831769: Various Cardiovascular Surgical Device, Research Industries Corp. (1983) Summary page 1.
- K033464: Edwards Lifesciences Research Medical Pediatric Venous Return Cannulae, Edwards Lifesciences, LLC (2004) Summary page 1.
- K092509: Edwards Lifesciences Venous Return Cannulae, Edwards Lifesciences, LLC (2009) Summary page 1.

## Recalls of this device
- Mar 7, 2018 · Class II · Z-3029-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Mar 7, 2018 · Class II · Z-3030-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Mar 7, 2018 · Class II · Z-3031-2018: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
- Nov 4, 2015 · Class II · Z-0398-2016: Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actua

## Indications for use
Single Stage Venous Cannulae: Venous return cannulae are intended for cannula drainage from the right atrium or superior and inferior vena cava during extracorporeal circulation for a duration of 6 hours. Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Dual Stage Venous Cannulae: 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. Venous cannulae may be used in pediatric populations or adult populations based on flow rate requirements and patient anatomy. Please see labeling for maximum flow rate information. 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/K120072
Methodology: https://510kreport.com/methodology