CATHSCANNER(R) PTA BALLOON DILATATION CATHETER

CATHSCANNER(R) PTA BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K902454) manufactured by Endosonics 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 August 29, 1990. Regulation: 8.