510(k) K933496

MAXIMA FILTERED HARDSHELL RESERVIOR by Medtronic Vascular — Product Code DTP

K933496 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MAXIMA FILTERED HARDSHELL RESERVIOR". The FDA issued a decision of Substantially Equivalent on October 15, 1993. 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.