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Spectranetics Corp.
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8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 is an FDA 510(k)-cleared medical device (K071226) manufactured by Spectranetics Corp.. 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 28, 2007. Regulation: 8.