MICRO GUIDE CATHETER ELITE

MICRO GUIDE CATHETER ELITE is an FDA 510(k)-cleared medical device (K140438) manufactured by Cordis Corp., A Johnson & Johnson Co.. 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 13, 2014. Regulation: 8.