ARROW GPSCATH BALLOON DILATATION CATHETER

ARROW GPSCATH BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K140351) manufactured by Hotspur Technologies,Inc Subsidiary of Teleflex ME. 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 1, 2014. Regulation: 8.