# K123187: Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter, Retrograde Cardioplegia Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Feb 22, 2013 after 134 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: 2 generations back to K880103 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K991170: Retrograde Cardioplegia Cannula with Duraflo Treatment, Model Dii-RC-014, Edwards Lifesciences Research Medical (1999) Summary page 1.
- K001565: Steerable Retrograde Cardioplegia Cannula with and Without Duraflo Treatment, Models SRCO14MIB, DIISRCO14MIB, Edwards Lifesciences, LLC (2000). Our reading of the summary gave K001665, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Steerable Retrograde Cardioplegia Cannula with and without Duraflo…”.

## Indications for use
Retrograde coronary sinus cardioplegia catheters with and without Duraflo coating are intended for delivery of blood or cardioplegia solution intraoperatively to avoid cardiac damage and aid in myocardial protection. Retrograde coronary sinus cardioplegia catheters may be used in pediatric or adult populations based on the requirements of individual patient anatomy. This device is for short-term use only (≤ 6 hours). Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.

Source page: https://510kreport.com/device/K123187
Methodology: https://510kreport.com/methodology