14 WIRE STANDARD, 14 WIRE LS

14 WIRE STANDARD, 14 WIRE LS is an FDA 510(k)-cleared medical device (K113454) manufactured by Micro Therapeutics, 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 February 23, 2012. Regulation: 8.