Name: Predicase
Price: 199 USD

K-number	K191077
Device name	Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
Applicant	Medtronic, Inc.
Product code	KFM
Device class	Class II
Decision date	Aug 27, 2019
Decision	Substantially Equivalent
Regulation	870.4360

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Source

View the full FDA submission: accessdata.fda.gov

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Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor

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