Spectrum Medical S.R.L. - FDA 510(k) Cleared Devices
Recent clearances: Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3), Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W, Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spectrum Medical S.R.L. Cardiovascular ✕
6 devices
Cleared
Mar 12, 2026
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3)
Cardiovascular
706d
Cleared
Mar 12, 2026
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
Cardiovascular
212d
Cleared
Aug 04, 2025
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors...
Cardiovascular
56d
Cleared
Jun 24, 2025
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors...
Cardiovascular
139d
Cleared
Jul 18, 2024
Quantum Perfusion Hybrid System
Cardiovascular
79d
Cleared
May 31, 2024
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
Cardiovascular
28d