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Intra Luminal Therapeutics, Inc.
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SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM is an FDA 510(k)-cleared medical device (K031842) manufactured by Intra Luminal Therapeutics, 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 November 20, 2003. Regulation: 8.