SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is an FDA 510(k)-cleared medical device (K170191) manufactured by Medtronic Vascular, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2017. Regulation: 8.