510(k) K182586

DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port by Medtronic, Inc. — Product Code DWF

K182586 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port". The FDA issued a decision of Substantially Equivalent on Oct 19, 2018. 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 247 other 510(k) clearances on record.