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Spectrum Medical S.R.L.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories5
Latest FDA decision2026-03-12
TypeNumberDevice NameCodeDateActions
510(k) K252541 Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WDTR2026-03-12 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);DTZ2026-03-12 View
510(k) K251762 Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM2025-08-04 View
510(k) K250326 Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)KFM2025-06-24 View
510(k) K241206 Quantum Perfusion Hybrid SystemDTN2024-07-18 View
510(k) K241248 Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)DWF2024-05-31 View
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