TRAXCESS 14 GUIDEWIRE

TRAXCESS 14 GUIDEWIRE is an FDA 510(k)-cleared medical device (K133725) manufactured by MicroVention, 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 July 30, 2014. Regulation: 8.