INSITE STEERABLE GUIDEWIRE

INSITE STEERABLE GUIDEWIRE is an FDA 510(k)-cleared medical device (K901224) 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 June 10, 1990. Regulation: 8.