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Spectranetics Corp.
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SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 is an FDA 510(k)-cleared medical device (K022138) 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 September 22, 2002. Regulation: 8.