TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE

TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE is an FDA 510(k)-cleared medical device (K093397) 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 December 16, 2009. Regulation: 8.