86ca52ad-ae30-4f43-a7c5-602396ea0cceNewPublished12020-12-282020-12-18In Commercial DistributionKG0830PrimaryHIBCCAeris Balloon Dilation CatheterKG0830160067273BRYAN MEDICAL, INC.1Aeris Balloon Dilation Catheter 8x30mmfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK15095100017827Bronchial balloon catheterA sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.falseActiveEOQBronchoscope (Flexible Or Rigid)truefalse