510(k) K063525

DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM by Datascope Corp. — Product Code DSP

K063525 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 5, 2007. 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.