Spectrum Medical S.R.L.
FDA 510(k) & PMA Approved Devices — 6 products
Total Devices6
Categories5
Latest Approval2026-03-12
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | DTR | 2026-03-12 | View |
| 510(k) | K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | DTZ | 2026-03-12 | View |
| 510(k) | K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | KFM | 2025-08-04 | View |
| 510(k) | K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | KFM | 2025-06-24 | View |
| 510(k) | K241206 | Quantum Perfusion Hybrid System | DTN | 2024-07-18 | View |
| 510(k) | K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | DWF | 2024-05-31 | View |
No matching devices.