# K253203: Retrograde Coronary Sinus Perfusion Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Feb 19, 2026 after 146 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: 1 generation back to K860149 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860149: Venous Perfusion Cannula W/Cuff Cat. NO. 94015, Dlp, Inc. (1986) Summary page 5.
- K953945: Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer Stylet, Dlp, Inc. (1996) Summary page 5.

## Indications for use
These cannulae are indicated for CPB procedures requiring delivery of cardioplegia in a retrograde direction through the coronary sinus for up to 6 hours in duration.

Source page: https://510kreport.com/device/K253203
Methodology: https://510kreport.com/methodology