Traxcess 7 Mini XSoft Guidewire

Traxcess 7 Mini XSoft Guidewire is an FDA 510(k)-cleared medical device (K163154) 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 8, 2016. Regulation: 8.