TORQUE TUBE STEEROCATH(TM)

TORQUE TUBE STEEROCATH(TM) is an FDA 510(k)-cleared medical device (K913375) manufactured by Ep 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 October 24, 1991. Regulation: 8.