# K260195: Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Apr 23, 2026 after 91 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K840002 (1984). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150422: EOPA 3D Arterial Cannula, Medtronic, Inc. (2015) Summary page 5.

## Recalls of this device
- Jun 24, 2026 · Class II · Z-2811-2026: Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
- Jun 24, 2026 · Class II · Z-2810-2026: Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

## Indications for use
These arterial cannulae are indicated for perfusion of the ascending or descending aorta for conditions requiring CPB procedures up to 6 hours in duration.

Source page: https://510kreport.com/device/K260195
Methodology: https://510kreport.com/methodology