510(k) K091449

DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 by Datascope Corp., Cardiac Assist Division — Product Code DSP

K091449 is an FDA 510(k) premarket notification submitted by Datascope Corp., Cardiac Assist Division for the device "DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02". The FDA issued a decision of Substantially Equivalent on June 18, 2009. 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.