# K924643: Medtronic Bio-Medicus Cannula Insertion Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Bio-Medicus, Inc.
- Decided: Dec 8, 1992 after 85 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
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System (2008), 7 descendants of its own
- K150567: Medtronic Bio-Medicus Cannula Insertion Kit (2015), 3 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K153598: Medtronic Bio-Medicus Adult Cannula Kit (2016), 1 descendant of its own

Source page: https://510kreport.com/device/K924643
Methodology: https://510kreport.com/methodology