LAKE REGION MANUFACTURING GUIDEWIRES

LAKE REGION MANUFACTURING GUIDEWIRES is an FDA 510(k)-cleared medical device (K981326) 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 July 9, 1998. Regulation: 8.