# K955818: Foamseal Retrograde Cardioplegia Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Mar 26, 1996 after 91 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 K880103 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941916: Quest Coronary Sinus Perfusion Cannula -FRCC, Quest Medical, Inc. (1995) Summary page 1.
- K880103: Catheter, Cannula and Tubing, Vascular, Cardiopul., Research Medical, Inc. (1988) Summary page 1.

## Indications for use
The FoamSeal Retrograde Cardioplegia Catheter is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

Source page: https://510kreport.com/device/K955818
Methodology: https://510kreport.com/methodology