510(k) K061369

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 by Cardiacassist, Inc. — Product Code DWA

K061369 is an FDA 510(k) premarket notification submitted by Cardiacassist, Inc. for the device "TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500". The FDA issued a decision of Substantially Equivalent on August 22, 2006. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Cardiacassist, Inc. has at least 10 other 510(k) clearances on record.