510(k) K170191

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System by Medtronic Vascular, Inc. — Product Code MCW

K170191 is an FDA 510(k) premarket notification submitted by Medtronic Vascular, Inc. for the device "SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System". The FDA issued a decision of Substantially Equivalent on June 16, 2017. 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.