# K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jun 20, 2025 after 58 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: 8 generations back to K840002 (1984). 78 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 80 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE, Medtronic, Inc. (2014) Summary page 5.

## Most influential descendants
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own

## Indications for use
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

Source page: https://510kreport.com/device/K251258
Methodology: https://510kreport.com/methodology