# K231773: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U

- Pathway: 510(k) (Traditional)
- Applicant: Qura S.R.L
- Decided: Nov 8, 2023 after 145 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- 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 K991737 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072091: D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/Venous Reservoir, Sorin Group Italia S.R.L. (2007) Summary page 6.

## Indications for use
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use. Device is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age). Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use. Devices is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).

Source page: https://510kreport.com/device/K231773
Methodology: https://510kreport.com/methodology