510(k) K050890

ECC.O SYSTEM by Dideco S.R.L. — Product Code KFM

K050890 is an FDA 510(k) premarket notification submitted by Dideco S.R.L. for the device "ECC.O SYSTEM". The FDA issued a decision of Substantially Equivalent on May 5, 2005. 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.R.L. has at least 10 other 510(k) clearances on record.