# K113411: Edward Vent Catheters Edward Vent Catheters with Duraflo Coating Dispersion Aortic Perfusion Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 11, 2012 after 206 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (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). 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)
- K831769: Various Cardiovascular Surgical Device, Research Industries Corp. (1983) Summary page 1.

## Recalls of this device
- Oct 8, 2014 · Class II · Z-0217-2015: Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.

## Indications for use
Atrial Vent Catheters are intended for venting the left heart during short-term (<6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium across the mitral valve and into the left ventricle. Left Ventricular Vent Catheters are intended for venting the left ventricle during short-term (<6 hrs) cardiopulmonary bypass. Entrance is made into the left ventricle. Extracorporeal circuit components with a Duraflo® coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Vent Catheters may be used in pediatric or adult populations based on individual patient anatomy.

Source page: https://510kreport.com/device/K113411
Methodology: https://510kreport.com/methodology