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Qura S.R.L FDA Approvals

0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2510(k)Sep 12, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 12, 2024
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-C1U510(k)Nov 8, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 8, 2023
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)510(k)Oct 26, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Oct 26, 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors510(k)May 19, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 19, 2023
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-VS510(k)Aug 18, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Aug 18, 2022
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set510(k)May 20, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 20, 2022
Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger510(k)May 6, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 6, 2022
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-C2U510(k)Jan 28, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 28, 2022
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger510(k)Jan 10, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 10, 2022
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-E2510(k)Dec 17, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 17, 2021
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F510(k)Nov 8, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 8, 2021
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor510(k)Nov 3, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 3, 2021
Quantum Perfusion Arterial Cannula Graft510(k)Jun 30, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 30, 2021

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