# K231206: DLP Silicone Coronary Artery Ostial Cannulae

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Dec 7, 2023 after 224 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: 4 generations back to K821149 (1982). 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)
- K141951: DLP Silicone Coronary Artery Ostial Cannulae, Medtronic, Inc. (2014) Summary page 4.

## Indications for use
The DLP Silicone Coronary Artery Ostial Cannulae, Models 30315, 30317, and 30320 are intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less for delivery of cardioplegia solutions directly to the coronary arteries.

Source page: https://510kreport.com/device/K231206
Methodology: https://510kreport.com/methodology