# K150567: Medtronic Bio-Medicus Cannula Insertion Kit

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Apr 9, 2015 after 34 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 K924643 (1992). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924643: Medtronic Bio-Medicus Cannula Insertion Kit, Medtronic Bio-Medicus, Inc. (1992) Summary page 4.

## Most influential descendants
- K153598: Medtronic Bio-Medicus Adult Cannula Kit (2016), 1 descendant of its own
- K190557: Bio-Medicus Insertion Kit (2019), 0 descendants of its own
- K180456: Bio-Medicus Adult Cannulae Kit (2018), 0 descendants of its own

## Indications for use
This kit is intended for use by trained physicians only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.

Source page: https://510kreport.com/device/K150567
Methodology: https://510kreport.com/methodology