K-number	K201320
Device name	Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Applicant	Qura S.R.L
Product code	KFM
Device class	Class II
Decision date	Nov 3, 2021
Decision	Substantially Equivalent
Regulation	870.4360

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Source

View the full FDA submission: accessdata.fda.gov

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Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor

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