MICRO-GUIDE SYSTEM

MICRO-GUIDE SYSTEM is an FDA 510(k)-cleared medical device (K884337) manufactured by Catheter Research C/O Burditt, Bowles & Radzius. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 1989. Regulation: 8.