# K180151: MC3 Jugular Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mc3 Incorporated
- Decided: Jul 16, 2018 after 178 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: 3 generations back to K003288 (2001). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171610: MC3 QuickFlow Dual Lumen Catheter, Mc3 Incorporated (2017) Summary page 4.

## Most influential descendants
- K232480: ProtekDuo Veno-Venous Cannula Sets (2023), 0 descendants of its own
- K203409: MC3 Crescent Jugular Dual Lumen Catheter (2021), 0 descendants of its own

## Indications for use
The MC3 Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in 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/K180151
Methodology: https://510kreport.com/methodology