BURRON TEFLON-COATED GUIDEWIRE

BURRON TEFLON-COATED GUIDEWIRE is an FDA 510(k)-cleared medical device (K884183) manufactured by Burron 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 August 2, 1989. Regulation: 8.