SILICONE COATED GUIDEWIRES

SILICONE COATED GUIDEWIRES is an FDA 510(k)-cleared medical device (K905581) manufactured by Lake Region Mfg., 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 February 18, 1991. Regulation: 8.