510(k) K941921

BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 by Medtronic Bio-Medicus, Inc. — Product Code DWA

K941921 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550". The FDA issued a decision of Substantially Equivalent on July 20, 1994. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.