
Trireme Medical, Inc.
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GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX is an FDA 510(k)-cleared medical device (K112281) 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 August 16, 2011. Regulation: 8.