Turbo-Elite Laser Atherectomy Catheter

Turbo-Elite Laser Atherectomy Catheter is an FDA 510(k)-cleared medical device (K250385) manufactured by Spectranetics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2025. Regulation: 8.