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Trireme Medical, Inc.
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CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) is an FDA 510(k)-cleared medical device (K120677) manufactured by Trireme Medical, 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 14, 2012. Regulation: 8.