# K024058: Modification to Cardeon Aegis Catheter

- Pathway: 510(k) (Special)
- Applicant: Cardeon Corp.
- Decided: Dec 30, 2002 after 21 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) Original Aegis Catheter: named in the summary without a submission number

## Indications for use
The Cardeon Aegis Catheter is intended to perfuse the aorta during open chest procedures on cardiopulmonary bypass up to 6 hours.

Source page: https://510kreport.com/device/K024058
Methodology: https://510kreport.com/methodology