# K201100: Bio-Medicus Life Support Catheter and Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jul 15, 2021 after 447 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: 4 generations back to K003288 (2001). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142673: Bio-Medicus Adult Cannulae and Introducer, Medtronic, Inc. (2014) Summary page 4.
- K143083: Bio-Medicus Pediatric Cannula and Introducers, Medtronic, Inc. (2015) Summary page 4.
- K180453: Bio-Medicus Adult Cannulae and Introducer, Medtronic, Inc. (2018) Summary page 4.

## Most influential descendants
- K251831: Bio-Medicus Life Support Catheter and Introducer (2026), 0 descendants of its own
- K240534: Bio-Medicus Life Support Catheter and Introducer (2024), 0 descendants of its own

## Indications for use
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately-sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.

Source page: https://510kreport.com/device/K201100
Methodology: https://510kreport.com/methodology