CRE Pulmonary Balloon Dilatation Catheter

CRE Pulmonary Balloon Dilatation Catheter is an FDA 510(k)-cleared medical device (K170759) manufactured by Boston Scientific Corporation. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2017. Regulation: 8.