K-number	K190650
Device name	Revolution Centrifugal Blood Pump
Applicant	Sorin Group Italia S.R.L.
Product code	KFM
Device class	Class II
Decision date	Aug 7, 2019
Decision	Substantially Equivalent
Regulation	870.4360

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Source

View the full FDA submission: accessdata.fda.gov

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Revolution Centrifugal Blood Pump

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