TurboHawk Plus Directional Atherectomy System

TurboHawk Plus Directional Atherectomy System is an FDA 510(k)-cleared medical device (K212027) manufactured by Medtronic, 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 August 23, 2021. Regulation: 8.