RADIFOCUS(R) (CATHETER) GUIDE WIRE

RADIFOCUS(R) (CATHETER) GUIDE WIRE is an FDA 510(k)-cleared medical device (K924202) manufactured by Terumo Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 22, 1992. Regulation: 8.