Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22

Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

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 Centrifugal Blood Pump Cp37, Quantum Pureflow Centrifugal Blood Pump Cp22.

Pre-market Notification Details

Device IDK202169
510k NumberK202169
Device Name:Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
ClassificationPump, Blood, Cardiopulmonary Bypass, Non-roller Type
Applicant Qura S.r.l Via Di Mezzo, 23 Mirandola,  IT 41037
ContactRaffaella Tommasini
CorrespondentRaffaella Tommasini
Qura S.r.l Via Di Mezzo, 23 Mirandola,  IT 41037
Product CodeKFM  
CFR Regulation Number870.4360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2020-09-02

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