# K180456: Bio-Medicus Adult Cannulae Kit

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Mar 22, 2018 after 30 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003288 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153598: Medtronic Bio-Medicus Adult Cannula Kit, Medtronic, Inc. (2016) Summary page 4.

## 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.

## Indications for use
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus™ cannula (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as venous return cannula. This product is intended for use up to 6 hours.

Source page: https://510kreport.com/device/K180456
Methodology: https://510kreport.com/methodology