# K093730: Port Access Systems Endodirect Arterial Cannula Model ED24 (Old Code Was-DFK24)

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 14, 2010 after 42 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) Edwards Lifesciences DirectFlow Arterial Cannula: named in the summary without a submission number

## Indications for use
The EndoDirect arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The cannula is intended to deliver oxygenated blood for cardiopulmonary bypass for a duration of less than 6 hours. The EndoDirect arterial cannula also allows the hemostatic introduction and removal of vascular catheters such as the Port Access EndoClamp aortic catheter. The EndloDirect arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor Introducer is intended for use with Port Access arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

Source page: https://510kreport.com/device/K093730
Methodology: https://510kreport.com/methodology