Medical Device Manufacturer · IT , Mirandola

Qura S.R.L

15 submissions · 15 cleared · Since 2020
15
Total
15
Cleared
0
Denied

Qura S.R.L — FDA 510(k) Submissions

Qura S.R.L has submitted 15 FDA 510(k) premarket notifications since 2020, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pump, Blood, Cardiopulmonary Bypass, Non-roller Type, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, Oxygenator, Cardiopulmonary Bypass, Heat-exchanger, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
K231982 · DTZ Oxygenator,... · Cardiovascular
Sep 2024 435d
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 Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
K231773 · DTZ Oxygenator,... · Cardiovascular
Nov 2023 145d
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
K233091 · KFM Pump, Blood,... · Cardiovascular
Oct 2023 30d
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
K220842 · KFM Pump, Blood,... · Cardiovascular
May 2023 422d
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-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS
K221353 · DWF Catheter, Cannula And... · Cardiovascular
Aug 2022 100d
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
K213540 · DWF Catheter, Cannula And... · Cardiovascular
May 2022 193d
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
K220110 · DTR Heat-exchanger,... · Cardiovascular
May 2022 113d
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 Integrated AF VT160-C2U
K212341 · DTZ Oxygenator,... · Cardiovascular
Jan 2022 184d
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
K212688 · DTR Heat-exchanger,... · Cardiovascular
Jan 2022 138d
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
K203424 · DTZ Oxygenator,... · Cardiovascular
Dec 2021 392d
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
K203067 · DWF Catheter, Cannula And... · Cardiovascular
Nov 2021 395d
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
K201320 · KFM Pump, Blood,... · Cardiovascular
Nov 2021 534d
Quantum Perfusion Arterial Cannula Graft
K203057 · DWF Catheter, Cannula And... · Cardiovascular
Jun 2021 265d
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
K202169 · KFM Pump, Blood,... · Cardiovascular
Sep 2020 30d
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
K192850 · KFM Pump, Blood,... · Cardiovascular
Apr 2020 193d
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