Company ยท IT
Qura S.R.L
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2024. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 2024 | K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 Qura S.R.L, IT | DTZ |
| Nov 8, 2023 | K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integ Qura S.R.L, IT | DTZ |
| Oct 26, 2023 | K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pu Qura S.R.L, IT | KFM |
| May 19, 2023 | K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 wit Qura S.R.L, IT | KFM |
| Aug 18, 2022 | K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula Qura S.R.L, IT | DWF |
| May 20, 2022 | K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set Qura S.R.L, IT | DWF |
| May 6, 2022 | K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger Qura S.R.L, IT | DTR |
| Jan 28, 2022 | K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Inte Qura S.R.L, IT | DTZ |
| Jan 10, 2022 | K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger Qura S.R.L, IT | DTR |
| Dec 17, 2021 | K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Bloo Qura S.R.L, IT | DTZ |
| Nov 8, 2021 | K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannu Qura S.R.L, IT | DWF |
| Nov 3, 2021 | K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor Qura S.R.L, IT | KFM |
| Jun 30, 2021 | K203057 | Quantum Perfusion Arterial Cannula Graft Qura S.R.L, IT | DWF |
| Sep 2, 2020 | K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Qura S.R.L, IT | KFM |
| Apr 13, 2020 | K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 Qura S.R.L, IT | KFM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2021 | QURA S.R.L. Spectrum Medical Quantum Standard heat exchanger Terminated |
KFM | None listed |