TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM is an FDA 510(k)-cleared medical device (K140775) manufactured by Spectranetics Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2014. Regulation: 8.