SKIPPER AND SKIPPER RACE GUIDEWIRE

SKIPPER AND SKIPPER RACE GUIDEWIRE is an FDA 510(k)-cleared medical device (K050756) manufactured by Invatec Innovative Technologies, S.R.L.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 4, 2005. Regulation: 8.