
Spectranetics Corp.
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CROSS-PILOT TURBO ELITE SUPPORT CATHETER is an FDA 510(k)-cleared medical device (K090913) 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 May 3, 2009. Regulation: 8.