510(k) K120868

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER by Datascope Corp., Cardiac Assist Division — Product Code DSP

K120868 is an FDA 510(k) premarket notification submitted by Datascope Corp., Cardiac Assist Division for the device "MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on April 20, 2012. The device falls under product code DSP (System, Balloon, Intra-Aortic And Control), a Class II device regulated under 21 CFR 870.3535. Datascope Corp., Cardiac Assist Division has at least 3 other 510(k) clearances on record.