Qura S.R.L - FDA 510(k) Cleared Devices
15
Total
15
Cleared
0
Denied
FDA 510(k) cleared devices by Qura S.R.L Cardiovascular ✕
15 devices
Cleared
Sep 12, 2024
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood...
Cardiovascular
435d
Cleared
Nov 08, 2023
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U,...
Cardiovascular
145d
Cleared
Oct 26, 2023
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)
Cardiovascular
30d
Cleared
May 19, 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors,...
Cardiovascular
422d
Cleared
Aug 18, 2022
Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen...
Cardiovascular
100d
Cleared
May 20, 2022
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
Cardiovascular
193d
Cleared
May 06, 2022
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia...
Cardiovascular
113d
Cleared
Jan 28, 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U,...
Cardiovascular
184d
Cleared
Jan 10, 2022
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat...
Cardiovascular
138d
Cleared
Dec 17, 2021
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood...
Cardiovascular
392d
Cleared
Nov 08, 2021
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen...
Cardiovascular
395d
Cleared
Nov 03, 2021
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Cardiovascular
534d