510(k) K231206

DLP Silicone Coronary Artery Ostial Cannulae by Medtronic, Inc. — Product Code DWF

K231206 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "DLP Silicone Coronary Artery Ostial Cannulae". The FDA issued a decision of Substantially Equivalent on December 7, 2023. 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, Inc. has at least 10 other 510(k) clearances on record.