# K203067: Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F

- Pathway: 510(k) (Traditional)
- Applicant: Qura S.R.L
- Decided: Nov 8, 2021 after 395 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; 1 cites 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)
- K180453: Bio-Medicus Adult Cannulae and Introducer, Medtronic, Inc. (2018) Summary page 8.
- K160257: PROTEK Duo 31 Fr. Veno-Venous Cannula Set, Cardiacassist, Inc. (2016) Summary page 8.

## Most influential descendants
- K221353: Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS (2022), 1 descendant of its own
- K241248: Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (2024), 0 descendants of its own

## Indications for use
The Quantum Perfusion Single Lumen Cannula 22F is designed to drain blood from the patient through the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours. The Quantum Perfusion Dual Lumen Cannula 24F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours. The Quantum Perfusion Dual Lumen Cannula 27F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours. The Quantum Perfusion Dual Lumen Cannula 31F is intended for use as a single cannula for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures for periods of maximum 6 hours.

Source page: https://510kreport.com/device/K203067
Methodology: https://510kreport.com/methodology