QURA S.R.L.
FDA Regulatory Profile
QURA S.R.L. appears in FDA public data with 1 recall, 15 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2277-2021, Class II) was initiated on March 22, 2021. Its most recent 510(k) clearance was granted on September 12, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2277-2021 | Class II | Spectrum Medical Quantum Standard heat exchanger | March 22, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | September 12, 2024 |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood O | November 8, 2023 |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion | October 26, 2023 |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal | May 19, 2023 |
| K221353 | Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusio | August 18, 2022 |
| K213540 | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | May 20, 2022 |
| K220110 | Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger | May 6, 2022 |
| K212341 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood | January 28, 2022 |
| K212688 | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | January 10, 2022 |
| K203424 | Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Qu | December 17, 2021 |
| K203067 | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfus | November 8, 2021 |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | November 3, 2021 |
| K203057 | Quantum Perfusion Arterial Cannula Graft | June 30, 2021 |
| K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | September 2, 2020 |
| K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | April 13, 2020 |