# K040173: Pediatric Aortic Root Cannula

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Mar 19, 2004 after 53 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 K790565 (1979). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790565: Aortic Root Cannula, Dlp, Inc. (1979) Summary page 1.
- K810548: Cardiopulminary Bypass Catheter Cannula, Dlp, Inc. (1981) Summary page 1.
- K831591: Aortic Root Cannula W/Integral Press, Dlp, Inc. (1983) Summary page 1.

## Most influential descendants
- K100274: Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014L (2010), 0 descendants of its own

## Indications for use
This cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

Source page: https://510kreport.com/device/K040173
Methodology: https://510kreport.com/methodology