LEXICONTURE MECHANICAL DILATOR SHEATH SET

LEXICONTURE MECHANICAL DILATOR SHEATH SET is an FDA 510(k)-cleared medical device (K140047) 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 April 8, 2014. Regulation: 8.