# K001565: Steerable Retrograde Cardioplegia Cannula with and Without Duraflo Treatment, Models SRCO14MIB, DIISRCO14MIB

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Aug 10, 2000 after 83 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K123187: Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter, Retrograde Cardioplegia Cannula (2013), 0 descendants of its own
- K090869: Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K001565
Methodology: https://510kreport.com/methodology