# K153598: Medtronic Bio-Medicus Adult Cannula Kit

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jan 15, 2016 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: 3 generations back to K003288 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites 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)
- K150567: Medtronic Bio-Medicus Cannula Insertion Kit, Medtronic, Inc. (2015) Summary page 4.
- K142673: Bio-Medicus Adult Cannulae and Introducer, Medtronic, Inc. (2014) Summary page 4.

## Most influential descendants
- K180456: Bio-Medicus Adult Cannulae Kit (2018), 0 descendants of its own

## Recalls of this device
- May 25, 2026 · Class II · Z-2739-2026: 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™ cannulae (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 a venous return cannula. This product is intended for use up to 6 hours.

Source page: https://510kreport.com/device/K153598
Methodology: https://510kreport.com/methodology