Name: Predicase
Price: 199 USD

K-number	K133074
Device name	MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
Applicant	Datascope Corp.
Product code	DSP
Device class	Class II
Decision date	Dec 12, 2013
Decision	Substantially Equivalent
Regulation	870.3535

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Source

View the full FDA submission: accessdata.fda.gov

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MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES

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