# K100274: Miar (Minimally Invasive Aortic Root) Cannula with Flow-Guard, Models 11012L and 11014L

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: May 10, 2010 after 101 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K790565 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
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.
- K040173: Pediatric Aortic Root Cannula, Medtronic Perfusion Systems (2004) Summary page 1.

## Recalls of this device
- Feb 5, 2025 · Class I · Z-1306-2025: Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and use

## Indications for use
The MiARTM cannula is intended for use during cardiopulmonary bypass for the delivery of cardiopiegia up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.

Source page: https://510kreport.com/device/K100274
Methodology: https://510kreport.com/methodology