Quantum PureFlow Standard Heat Exchanger And Quantum PureFlow Cardioplegia Heat Exchanger

Heat-exchanger, Cardiopulmonary Bypass

Qura S.r.l.

The following data is part of a premarket notification filed by Qura S.r.l. with the FDA for Quantum Pureflow Standard Heat Exchanger And Quantum Pureflow Cardioplegia Heat Exchanger.

Pre-market Notification Details

Device IDK220110
510k NumberK220110
Device Name:Quantum PureFlow Standard Heat Exchanger And Quantum PureFlow Cardioplegia Heat Exchanger
ClassificationHeat-exchanger, Cardiopulmonary Bypass
Applicant Qura S.r.l. Via Di Mezzo, 23 Mirandola,  IT 41037
ContactRaffaella Tommasini
Product CodeDTR  
CFR Regulation Number870.4240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-13
Decision Date2022-05-06
Summary:summary

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