Name: Predicase
Price: 199 USD

K-number	K202169
Device name	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Applicant	Qura S.R.L
Product code	KFM
Device class	Class II
Decision date	Sep 2, 2020
Decision	Substantially Equivalent
Regulation	870.4360

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.