INTRALUMINAL ARTERY STRIPPER

INTRALUMINAL ARTERY STRIPPER is an FDA 510(k)-cleared medical device (K913803) manufactured by Omni-Tract Surgical, Div. Minn. Scientific, 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 April 23, 1992. Regulation: 8.