510(k) K926357

MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150 by Medtronic Bio-Medicus, Inc. — Product Code DWA

K926357 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150". The FDA issued a decision of Substantially Equivalent on June 2, 1993. 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.