# K262052: Tri Stage Venous Cannulae

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Sep 28, 2026 after 102 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: 9 generations back to K840002 (1984). 80 ancestors in all.
No later device cites it as a predicate yet.
1 of 81 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula, Medtronic, Inc. (2025) Summary page 5.
- K943934: Aortic Arch Cannulas, Sorin Group Italia S.R.L. (1995) Summary page 6.

## Indications for use
The Tri Stage Venous Cannula is indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery for up to six hours. The proposed patien population is Adults and Adolescents.

Source page: https://510kreport.com/device/K262052
Methodology: https://510kreport.com/methodology