
Lumend, Inc.
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LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES is an FDA 510(k)-cleared medical device (K033535) manufactured by Lumend, Inc.. 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 6, 2004. Regulation: 8.