ONTRAC STEERABLE GUIDEWIRE

ONTRAC STEERABLE GUIDEWIRE is an FDA 510(k)-cleared medical device (K941229) manufactured by Lake Region Mfg., 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 May 11, 1994. Regulation: 8.