# K991170: Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences Research Medical
- Decided: Jul 2, 1999 after 86 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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.
- K932208: Extracorporeal Circuit W/Duraflo II Heparin Treatm, Baxter Healthcare Corp (1994) Summary page 1.

## Most influential descendants
- K123187: Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter, Retrograde Cardioplegia Cannula (2013), 0 descendants of its own

## Indications for use
The Retrograde Cardioplegia Cannula with Duraflo Treatment is indicated for use in the dalivery of blood or cardiopteglc solution intraaperatively. Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired. This device is for short-term use only (< 6 h).

Source page: https://510kreport.com/device/K991170
Methodology: https://510kreport.com/methodology