# K131269: DLP Coronary Ostial Perfusion Cannulae

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jul 10, 2013 after 68 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K821149 (1982). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034058: Spherical Tip Coronary Ostial Cannula, Model 30011, Medtronic Vascular (2004) Summary page 1.

## Most influential descendants
- K141951: DLP Silicone Coronary Artery Ostial Cannulae (2014), 2 descendants of its own
- K231206: DLP Silicone Coronary Artery Ostial Cannulae (2023), 0 descendants of its own
- K230960: DLP™ Silicone Coronary Artery Ostial Cannulae (2023), 0 descendants of its own

## Recalls of this device
- Mar 19, 2024 · Class II · Z-1795-2024: Potential for unsealed sterile packing.

## Indications for use
These Cannulae 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/K131269
Methodology: https://510kreport.com/methodology