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Therox, Inc.
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THEROX INFUSION CATHETER, MODEL INCA-1 is an FDA 510(k)-cleared medical device (K052637) manufactured by Therox, 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 March 7, 2006. Regulation: 8.