# K964193: Chase Aortic Arch Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Chase Medical, Inc.
- Decided: Apr 16, 1997 after 177 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
Longest line of descent: 1 generation back to K770429 (1977). 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)
- K770429: Cannulae, Aortic, Arch, High Flow, 3M Health Care, Sarns (1977) Summary page 1.

## Indications for use
The Aortic Arch Cannula is indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass in cases where aortic perfusion is deemed appropriate.

Source page: https://510kreport.com/device/K964193
Methodology: https://510kreport.com/methodology