MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)

MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) is an FDA 510(k)-cleared medical device (K003483) 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 December 5, 2000. Regulation: 8.