# K024069: One Piece Pediatric Arterial Cannula, Model: 77006, 77106

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Jan 8, 2003 after 29 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: 1 generation back to K840001 (1984). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840001: Arterial Cannula Straight Beveled Tip, Dlp, Inc. (1984) Summary page 1.

## Most influential descendants
- K143083: Bio-Medicus Pediatric Cannula and Introducers (2015), 3 descendants of its own
- K201100: Bio-Medicus Life Support Catheter and Introducer (2021), 2 descendants of its own
- K251831: Bio-Medicus Life Support Catheter and Introducer (2026), 0 descendants of its own
- K240534: Bio-Medicus Life Support Catheter and Introducer (2024), 0 descendants of its own
- K112565: Novaport One Vascular Access Cannula (2011), 0 descendants of its own

## Recalls of this device
- May 25, 2026 · Class II · Z-2738-2026: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- Dec 12, 2024 · Class II · Z-0984-2025: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

## Indications for use
These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.

Source page: https://510kreport.com/device/K024069
Methodology: https://510kreport.com/methodology