THE GUIDER CORONARY GUIDING CATHETER

THE GUIDER CORONARY GUIDING CATHETER is an FDA 510(k)-cleared medical device (K903216) manufactured by Intec Medical, 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 October 18, 1990. Regulation: 8.