510(k) K082746

ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 by Insightra Medical, Inc. — Product Code DSP

K082746 is an FDA 510(k) premarket notification submitted by Insightra Medical, Inc. for the device "ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20". The FDA issued a decision of Substantially Equivalent on January 12, 2009. The device falls under product code DSP (System, Balloon, Intra-Aortic And Control), a Class II device regulated under 21 CFR 870.3535. Insightra Medical, Inc. has at least 3 other 510(k) clearances on record.