510(k) K030154

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

K030154 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR". The FDA issued a decision of Substantially Equivalent on Mar 31, 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 32 other 510(k) clearances on record.