Name: Predicase
Price: 199 USD

K-number	K120868
Device name	MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
Applicant	Datascope Corp., Cardiac Assist Division
Product code	DSP
Device class	Class II
Decision date	Apr 20, 2012
Decision	Substantially Equivalent
Regulation	870.3535

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View the full FDA submission: accessdata.fda.gov

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MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER

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