0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)

0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) is an FDA 510(k)-cleared medical device (K143093) manufactured by Hotspur Technologies, Inc.,. 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 23, 2015. Regulation: 8.