510(k) K924643

MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT by Medtronic Bio-Medicus, Inc. — Product Code DWF

K924643 is an FDA 510(k) premarket notification submitted by Medtronic Bio-Medicus, Inc. for the device "MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT". The FDA issued a decision of Substantially Equivalent on December 8, 1992. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Medtronic Bio-Medicus, Inc. has at least 10 other 510(k) clearances on record.