510(k) K911789

MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT by Medtronic Vascular — Product Code DTP

K911789 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT". The FDA issued a decision of Substantially Equivalent on August 20, 1991. 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.