LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)

LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW) is an FDA 510(k)-cleared medical device (K871882) 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 September 14, 1987. Regulation: 8.