510(k) K001602

DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) by Dideco S.P.A. — Product Code DTN

K001602 is an FDA 510(k) premarket notification submitted by Dideco S.P.A. for the device "DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)". The FDA issued a decision of Substantially Equivalent on Jun 8, 2000. 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.