510(k) K032040

IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR by Dideco S.P.A. — Product Code KFM

K032040 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR". The FDA issued a decision of Substantially Equivalent on July 9, 2003. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Dideco S.P.A. has at least 10 other 510(k) clearances on record.