SLIDEWIRETM(TRADEMARK PENDING)

SLIDEWIRETM(TRADEMARK PENDING) is an FDA 510(k)-cleared medical device (K113162) manufactured by Acme-Monaco 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 July 19, 2012. Regulation: 8.