LAKE REGION HYDROPHILIC GUIDEWIRE

LAKE REGION HYDROPHILIC GUIDEWIRE is an FDA 510(k)-cleared medical device (K040825) 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 May 16, 2004. Regulation: 8.