This page includes the latest FDA filings for Qura S R L. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 0 |
| FEI Number | 0 |
| Name | Colleen Powell |
| Owner & Operator | Qura S.r.l. |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 5 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 481 Munn Road, Suite 180 Fort Mills, SC 29715 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| QURA SRL | Quantum Perfusion Capnometer Line Set | 2023-08-18 |
| QURA SRL | Quantum Perfusion Centrifugal Blood Pump CP20 | 2023-07-05 |
| QURA SRL | Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | 2023-07-05 |
| QURA SRL | Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 M | 2023-05-12 |
| QURA SRL | Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 M | 2023-05-12 |
| QURA SRL | Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 | 2023-05-12 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 24F-V1 | 2022-09-13 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 27F-V1 | 2022-09-13 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 29F-V1 | 2022-09-13 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 29F | 2022-09-13 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 27F-VS | 2022-09-13 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 31F-VS | 2022-09-13 |
Qura S.r.l. | 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 | 2022-08-18 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP02C-BC | 2022-07-22 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP02C-AB | 2022-07-22 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP02C-DA | 2022-07-22 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP02V-BB | 2022-07-22 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP02V-AA | 2022-07-22 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP02E-CC | 2022-07-22 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP02E-BB | 2022-07-22 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP03E-AA | 2022-06-15 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP02E-AA | 2022-06-15 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP01V-AA | 2022-06-15 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP01C-DA | 2022-06-15 |
| QURA SRL | Quantum SuperPAC Tubing Set - SP01E-AA | 2022-06-15 |
| QURA SRL | Quantum SuperPAC Cardioplegia Set 3/16 - PL | 2022-06-15 |
| QURA SRL | Quantum SuperPAC Cardioplegia Set 1/4 - PL | 2022-06-15 |
| QURA SRL | Quantum SuperPAC Cardioplegia Set 3/16 | 2022-06-15 |
| QURA SRL | Quantum SuperPAC Cardioplegia Set 1/4 | 2022-06-15 |
| QURA SRL | Quantum PureFlow Standard Heat Exchanger Medium Flow 3/8 | 2022-06-07 |
| QURA SRL | Quantum Perfusion KIT CPC - Hansen Connector Adaptor | 2022-05-26 |
| QURA SRL | Quantum Perfusion KIT CPC - Barbed Connector Adaptor | 2022-05-26 |
Qura S.r.l. | Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set | 2022-05-20 |
Qura S.r.l. | Quantum PureFlow Standard Heat Exchanger And Quantum PureFlow Cardioplegia Heat Exchanger | 2022-05-06 |
| QURA SRL | Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U | 2022-02-24 |
| QURA SRL | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | 2022-02-24 |
| QURA SRL | Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U | 2022-02-24 |
| QURA SRL | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U | 2022-02-24 |
| QURA SRL | Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 - PL | 2022-02-24 |
| QURA SRL | Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 - PL | 2022-02-24 |
| QURA SRL | Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 - PL | 2022-02-24 |
| QURA SRL | Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 | 2022-02-24 |
| QURA SRL | Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 | 2022-02-24 |
| QURA SRL | Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 | 2022-02-24 |
| QURA SRL | Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 | 2022-02-24 |
| QURA SRL | Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 | 2022-02-24 |
| QURA SRL | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 | 2022-02-24 |
| QURA SRL | Quantum PureFlow Standard Heat Exchanger High Flow 3/8 | 2022-02-24 |
Qura S.r.l. | 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 | 2022-01-28 |
Qura S.r.l. | Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger | 2022-01-10 |
| QURA SRL | Quantum Perfusion Blood Oxygenator ECC VT160-E2 | 2021-12-31 |
| QURA SRL | Quantum Perfusion Blood Oxygenator ECC VT160-E1 | 2021-12-31 |
| QURA SRL | Quantum Perfusion Blood Oxygenator ECC VT200-E2 | 2021-12-31 |
| QURA SRL | Quantum Perfusion Blood Oxygenator ECC VT200-E1 | 2021-12-31 |
| QURA SRL | Quantum Perfusion Single Lumen Cannula 22F | 2021-12-28 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 24F | 2021-12-28 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 27 | 2021-12-28 |
| QURA SRL | Quantum Perfusion Dual Lumen Cannula 31F | 2021-12-28 |
Qura S.r.l. | 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 | 2021-12-17 |
| QURA SRL | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors | 2021-11-23 |
Qura S.r.l. | Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F | 2021-11-08 |
Qura S.r.l. | Quantum PureFlow Centrifugal Blood Pump CP22 With Integrated Sensor | 2021-11-03 |
| QURA SRL | Quantum Perfusion Arterial Cannula Graft | 2021-08-16 |
Qura S.r.l. | Quantum Perfusion Arterial Cannula Graft | 2021-06-30 |
Qura S.r.l | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | 2020-09-02 |
| QURA SRL | Quantum PureFlow Centrifugal Blood Pump CP37 | 2020-05-05 |
| QURA SRL | Quantum PureFlow Centrifugal Blood Pump CP22 | 2020-05-05 |
Colleen Powell [Qura S.r.l.] | Quantum PureFlow Centrifugal Blood Pump | 2020-04-16 |
Qura S.r.l. | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | 2020-04-13 |