# K190557: Bio-Medicus Insertion Kit

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Apr 3, 2019 after 29 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: 2 generations back to K924643 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Recalls of this device
- Sep 13, 2021 · Class II · Z-0003-2022: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

## 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/K190557
Methodology: https://510kreport.com/methodology