Cleared Traditional

Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger

K220110 · Qura S.R.L · Cardiovascular
May 2022
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K220110 is an FDA 510(k) clearance for the Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on May 6, 2022, 113 days after receiving the submission on January 13, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.

Submission Details

510(k) Number K220110 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2022
Decision Date May 06, 2022
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTR — Heat-exchanger, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4240

Similar Devices — DTR Heat-exchanger, Cardiopulmonary Bypass

All 90
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
K252541 · Spectrum Medical S.R.L. · Mar 2026
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
K240908 · Spectrum Medical , Ltd. · Jul 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
K250150 · Sorin Group Italia S.R.L. · May 2025
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
K240190 · Medtronic · Feb 2024
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
K223879 · Quara S.R.L. · Apr 2023
Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
K212688 · Qura S.R.L · Jan 2022

More from Qura S.R.L

View all
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
K231982 · DTZ · Sep 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-C1U
K231773 · DTZ · Nov 2023
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
K233091 · KFM · Oct 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
K220842 · KFM · May 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-VS
K221353 · DWF · Aug 2022