# K964393: Chase Retrograde Cardioplegia Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Chase Medical, Inc.
- Decided: Apr 23, 1997 after 170 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880103 (1988). 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)
- K880103: Catheter, Cannula and Tubing, Vascular, Cardiopul., Research Medical, Inc. (1988) Summary page 1.

## Recalls of this device
- Apr 17, 2007 · Not classified · Z-0892-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0893-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0894-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0897-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0901-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0903-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0895-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0896-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0898-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0899-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0900-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0902-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
- Apr 17, 2007 · Not classified · Z-0904-2007: The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.

## Indications for use
The Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery.

Source page: https://510kreport.com/device/K964393
Methodology: https://510kreport.com/methodology