# K132995: DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Line, DLP Retrograde Coronary Sinus Perfusio

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Oct 31, 2013 after 37 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 K860149 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030696: Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French, Manual and Auto Inflate), Medtronic Perfusion Systems (2003) Summary page 1.

## Indications for use
The cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrogradely through the coronary sinus up to six hours or less.

Source page: https://510kreport.com/device/K132995
Methodology: https://510kreport.com/methodology