Chrysalis Intelligence · Sponsors · Qura S.R.L

Qura S.R.L

Mirandola, IT · 15 510(k) clearances

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Total clearances
15
2020-04-13 → 2024-09-12
Last 12 months
0
Product codes
4
Most recent
2024-09-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class II Cardiovascular 5 2023-10-26
DTZ Oxygenator, Cardiopulmonary Bypass Class II Cardiovascular 4 2024-09-12
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Class II Cardiovascular 4 2022-08-18
DTR — — — 2 2022-05-06
Filings

All 510(k) clearances (15)

Date K-number Device Code Class Specialty
2024-09-12 K231982 Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 DTZ Class II Cardiovascular
2023-11-08 K231773 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 DTZ Class II Cardiovascular
2023-10-26 K233091 Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) KFM Class II Cardiovascular
2023-05-19 K220842 Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors KFM Class II Cardiovascular
2022-08-18 K221353 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 DWF Class II Cardiovascular
2022-05-20 K213540 Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set DWF Class II Cardiovascular
2022-05-06 K220110 Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger DTR — —
2022-01-28 K212341 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 DTZ Class II Cardiovascular
2022-01-10 K212688 Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger DTR — —
2021-12-17 K203424 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 DTZ Class II Cardiovascular
2021-11-08 K203067 Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F DWF Class II Cardiovascular
2021-11-03 K201320 Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor KFM Class II Cardiovascular
2021-06-30 K203057 Quantum Perfusion Arterial Cannula Graft DWF Class II Cardiovascular
2020-09-02 K202169 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 KFM Class II Cardiovascular
2020-04-13 K192850 Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 KFM Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence