ACCLARENT Balloon Inflation Medical Device 32269

EXPIRED: 12-31-22 Catalogue Number: BID30 Disclosures Important Safety Information: ACCLARENT AERA Eustachian Tube Balloon Dilation System is intended for use by physicians who are trained on Acclarent Technology. Eustachian tube balloon dilation has associated risks, including tissue and mucosal trauma, infection, or possible carotid artery injury. ACCLARENT Balloon Sinuplasty Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent Technology. ACCLARENT Balloon Sinuplasty Device use has described risks, including tissue and mucosal trauma, infection, or possible orbital injury. The RELIEVA TRACT Nasal Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and trans-nasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. The RELIEVA TRACT Nasal Balloon Dilation System is intended for use in ages 17 years or older. Balloon dilation catheters should be used by or under supervision of physicians thoroughly trained in balloon dilation. A thorough understanding of the technical principles, clinical application, and risk associated with balloon dilation of the nasal passage is necessary before using this device,