510(k) K992599

DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR by Dideco S.P.A. — Product Code DTN

K992599 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR". The FDA issued a decision of Substantially Equivalent on Nov 1, 1999. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Dideco S.P.A. has 32 other 510(k) clearances on record.