QURA S.R.L.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2277-2021Class IISpectrum Medical Quantum Standard heat exchangerMarch 22, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2September 12, 2024
K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood ONovember 8, 2023
K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion October 26, 2023
K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion CentrifugalMay 19, 2023
K221353Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum PerfusioAugust 18, 2022
K213540Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia SetMay 20, 2022
K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerMay 6, 2022
K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood January 28, 2022
K212688Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat ExchangerJanuary 10, 2022
K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, QuDecember 17, 2021
K203067Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum PerfusNovember 8, 2021
K201320Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorNovember 3, 2021
K203057Quantum Perfusion Arterial Cannula GraftJune 30, 2021
K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22September 2, 2020
K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22April 13, 2020