CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)

CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) is an FDA 510(k)-cleared medical device (K121398) manufactured by Guidepath Medical, 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 12, 2012. Regulation: 8.