510(k) K902355

MCR4000 & MCR4000F CARDIOTOMY RESERVOIR by Medtronic Vascular — Product Code DTP

K902355 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MCR4000 & MCR4000F CARDIOTOMY RESERVOIR". The FDA issued a decision of Substantially Equivalent on August 23, 1990. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230. Medtronic Vascular has at least 10 other 510(k) clearances on record.