ARROW GPSCATH BALLOON DILATATION CATHETER

ARROW GPSCATH BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K130397) manufactured by Hotspur Technologies. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 2013. Regulation: 8.