010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF

010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF is an FDA 510(k)-cleared medical device (K914828) manufactured by Advanced Cardiovascular Systems, 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 January 7, 1992. Regulation: 8.