# K203409: MC3 Crescent Jugular Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mc3, Inc.
- Decided: May 3, 2021 after 165 days
- Product code: PZS (Dual 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
Longest line of descent: 4 generations back to K003288 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180151: MC3 Jugular Dual Lumen Catheter, Mc3 Incorporated (2018)

## Indications for use
The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, 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/K203409
Methodology: https://510kreport.com/methodology