510(k) K253998

Clearview Intracoronary Shunts by Medtronic, Inc. — Product Code DWF

K253998 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Clearview Intracoronary Shunts". The FDA issued a decision of Substantially Equivalent on January 20, 2026. 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.