FDA 510(k) Applications Submitted by Raffaella Tommasini
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220110 |
01/13/2022 |
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger |
Qura S.r.l. |
| K250326 |
02/05/2025 |
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) |
Spectrum Medical S.r.l. |
| K220842 |
03/23/2022 |
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors |
Qura S.r.l. |
| K241206 |
04/30/2024 |
Quantum Perfusion Hybrid System |
Spectrum Medical S.r.l. |
| K241248 |
05/03/2024 |
Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) |
Spectrum Medical s.r.l. |
| K221353 |
05/10/2022 |
Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V |
Qura S.r.l. |
| K201320 |
05/18/2020 |
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor |
Qura S.r.l. |
| K231773 |
06/16/2023 |
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with |
Qura S.r.l. |
| K231982 |
07/05/2023 |
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 |
Qura S.r.l. |
| K212341 |
07/28/2021 |
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with |
Qura S.r.l. |
| K202169 |
08/03/2020 |
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 |
Qura S.r.l |
| K212688 |
08/25/2021 |
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger |
Qura S.r.l. |
| K233091 |
09/26/2023 |
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) |
Qura S.r.l. |
| K192850 |
10/03/2019 |
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 |
Qura S.r.l. |
| K203057 |
10/08/2020 |
Quantum Perfusion Arterial Cannula Graft |
Qura S.r.l. |
| K203067 |
10/09/2020 |
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F |
Qura S.r.l. |
| K213540 |
11/08/2021 |
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set |
Qura S.r.l. |
| K203424 |
11/20/2020 |
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 |
Qura S.r.l. |
| K223879 |
12/27/2022 |
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) |
Quara S.r.l. |
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