510(k) K161361

HawkOne Directional Atherectomy System by Medtronic Vascular, Inc. — Product Code MCW

K161361 is an FDA 510(k) premarket notification submitted by Medtronic Vascular, Inc. for the device "HawkOne Directional Atherectomy System". The FDA issued a decision of Substantially Equivalent on October 14, 2016. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Medtronic Vascular, Inc. has at least 10 other 510(k) clearances on record.