Quantum PureFlow Centrifugal Blood Pump CP22 With Integrated Sensor

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 Cp22 With Integrated Sensor.

Pre-market Notification Details

Device IDK201320
510k NumberK201320
Device Name:Quantum PureFlow Centrifugal Blood Pump CP22 With Integrated Sensor
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-18
Decision Date2021-11-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08051160300624 K201320 000

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