Name: Predicase
Price: 199 USD

K-number	K163542
Device name	CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
Applicant	Datascope Corp.
Product code	DSP
Device class	Class II
Decision date	Jan 31, 2017
Decision	Substantially Equivalent
Regulation	870.3535

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Source

View the full FDA submission: accessdata.fda.gov

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CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case

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