NITREX NITINOL GUIDEWIRE

NITREX NITINOL GUIDEWIRE is an FDA 510(k)-cleared medical device (K031864) manufactured by Ev3 Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 2003. Regulation: 8.