# K964198: Cahse Aortic Root Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Chase Medical, Inc.
- Decided: Mar 19, 1997 after 149 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 K790565 (1979). 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)
- K790565: Aortic Root Cannula, Dlp, Inc. (1979) Summary page 1.

## Indications for use
Chase Medical aortic root cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

Source page: https://510kreport.com/device/K964198
Methodology: https://510kreport.com/methodology