Turbo-Power Laser Atherectomy Catheter

Turbo-Power Laser Atherectomy Catheter is an FDA 510(k)-cleared medical device (K152181) manufactured by Spectranetics, 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 November 11, 2015. Regulation: 8.