ROADRUNNER(TM) WIRE GUIDE, MODIFICATION

ROADRUNNER(TM) WIRE GUIDE, MODIFICATION is an FDA 510(k)-cleared medical device (K920891) manufactured by Cook, 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 20, 1992. Regulation: 8.