Qura S.R.L
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories4
Latest FDA decision2024-09-12
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | DTZ | 2024-09-12 | View |
| 510(k) | 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 | DTZ | 2023-11-08 | View |
| 510(k) | K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | KFM | 2023-10-26 | View |
| 510(k) | K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | KFM | 2023-05-19 | View |
| 510(k) | 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 | DWF | 2022-08-18 | View |
| 510(k) | K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | DWF | 2022-05-20 | View |
| 510(k) | K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | DTR | 2022-05-06 | View |
| 510(k) | K212341 | 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,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U | DTZ | 2022-01-28 | View |
| 510(k) | K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | DTR | 2022-01-10 | View |
| 510(k) | K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 | DTZ | 2021-12-17 | View |
| 510(k) | 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 | DWF | 2021-11-08 | View |
| 510(k) | K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | KFM | 2021-11-03 | View |
| 510(k) | K203057 | Quantum Perfusion Arterial Cannula Graft | DWF | 2021-06-30 | View |
| 510(k) | K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | KFM | 2020-09-02 | View |
| 510(k) | K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | KFM | 2020-04-13 | View |
No matching devices.