# K061254: Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Jun 23, 2006 after 50 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: 4 generations back to K840002 (1984). 7 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033416: Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface, Medtronic Perfusion Systems (2003) Summary page 1.
- K043179: Select 3D Arterial Cannula, Medtronic Perfusion Systems (2005) Summary page 1.

## Most influential descendants
- 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
- K150422: EOPA 3D Arterial Cannula (2015), 1 descendant of its own

## Indications for use
These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

Source page: https://510kreport.com/device/K061254
Methodology: https://510kreport.com/methodology