
Spectranetics Corp.
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TURBO-TANDEM SYSTEM MODEL 472-110 is an FDA 510(k)-cleared medical device (K094036) 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 January 24, 2010. Regulation: 8.