# K964199: Chase Coronary Sinus Perfusion 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: 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 K941166 (1995). 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)
- K941166: Quest Coronary Sinus Perfusion Cannula, Quest Medical, Inc. (1995) Summary page 1.

## Recalls of this device
- Jul 18, 2018 · Class II · Z-0068-2019: The device was built with the rigid insertion stylet instead of the flexible stylet.

## Indications for use
The CHASE coronary sinus perfusion cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

Source page: https://510kreport.com/device/K964199
Methodology: https://510kreport.com/methodology