510(k) K163542

CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case by Datascope Corp. — Product Code DSP

K163542 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case". The FDA issued a decision of Substantially Equivalent on January 31, 2017. 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. has at least 10 other 510(k) clearances on record.