Traxcess 14 SELECT Guidewire

Traxcess 14 SELECT Guidewire is an FDA 510(k)-cleared medical device (K200547) 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 April 15, 2020. Regulation: 8.