FDA-Device2013-08-07Class II
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Acclarent, Inc.
Hazard
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Affected count
2175
Manufactured in
1525-B O'Brien Dr, N/A, Menlo Park, CA, United States
Products
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1866-2013Don't want to check this manually?
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