K-number	K110845
Device name	IMPELLA CONTROLLER WITH FLOW CONTROL
Applicant	Abiomed, Inc.
Product code	KFM
Device class	Class II
Decision date	Apr 27, 2011
Decision	Substantially Equivalent
Regulation	870.4360

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View the full FDA submission: accessdata.fda.gov

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IMPELLA CONTROLLER WITH FLOW CONTROL

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