# K031776: MC2X Multi-Stage Venous Cannula

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Jul 25, 2003 after 45 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 K891687 (1989). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915268: Catheter Two Stage Venous Return, Dlp, Inc. (1992) Summary page 1.
- K891687: Extracorporeal Circuit with Bio-Active Surface, Medtronic Blood Systems, Inc. (1989) Summary page 1.

## Most influential descendants
- K052372: MC2X Multi-Stage Venous Cannula, Models 91437, 91437C (2005), 6 descendants of its own
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant 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/K031776
Methodology: https://510kreport.com/methodology