# K201057: Bio-Medicus Life Support Catheter and Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jan 14, 2022 after 633 days
- Product code: QHW (Single Lumen Ecmo Cannula)
- Device class: 2
- Regulation: 21 CFR 870.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FDA Final Order 81 FR 7451, February 12, 2016: named in the summary without a submission number

## 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
The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

Source page: https://510kreport.com/device/K201057
Methodology: https://510kreport.com/methodology