# K113667: Cardioplegia Delivery Sets Cardioplegia Delivery Sets with Duraflo Coating

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jan 12, 2012 after 30 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- 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 K892368 (1989). 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)
- K892368: Rmi Cardioplegia Delivery Sets, Research Medical, Inc. (1989) Summary page 1.

## Indications for use
Cardioplegia Delivery Sets are intended for use as adapters for connecting cardioplegia administration tubing to cardioplegia delivery catheters. 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/K113667
Methodology: https://510kreport.com/methodology