ASTRO TRACE (MODEL AT-02)

ASTRO TRACE (MODEL AT-02) is an FDA 510(k)-cleared medical device (K885137) manufactured by The LE Blanc Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 1989. Regulation: 8.