AGILTRAC .035 PERIPHERAL DILATATION CATHETER

AGILTRAC .035 PERIPHERAL DILATATION CATHETER is an FDA 510(k)-cleared medical device (K022738) manufactured by Guidant 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 September 12, 2002. Regulation: 8.