Jade PTA Balloon Dilatation Catheter

Jade PTA Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K173894) manufactured by Orbusneich Medical Trading, 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 February 8, 2018. Regulation: 8.