510(k) K122628

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

K122628 is an FDA 510(k) premarket notification submitted by Datascope Corp., Cardiac Assist Division for the device "SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on September 6, 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.