# K171610: MC3 QuickFlow Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mc3 Incorporated
- Decided: Nov 16, 2017 after 168 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: 2 generations back to K003288 (2001). 2 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K081820: Avalon Elite BI-Caval Dual Lumen Catheter, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR, Avalon Laboratories, LLC (2008) Summary page 4.

## Most influential descendants
- K180151: MC3 Jugular Dual Lumen Catheter (2018), 2 descendants of its own
- 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 26 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3l/min) where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent. The MC3 28 Fr. QuickFlow™ Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the femoral vein, that is indicated for use for up to 72 hours in patients with acute respiratory failure requiring partial Veno-Venous Extracorporeal Membrane Oxygenation (full hemodynamic support is not required and predicted flows needed to maintain adequate oxygenation do not exceed 3.5l/min) 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/K171610
Methodology: https://510kreport.com/methodology