TXM Hydrophilic Guidewire

TXM Hydrophilic Guidewire is an FDA 510(k)-cleared medical device (K170915) manufactured by Texasmedical Technologies, 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, 2017. Regulation: 8.