Device product
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Z-1865-2013
Product summary
- Firm
- Acclarent, Inc.
- Event
- Event 64625
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3324
- Official record key
device-enforcement:Z-1865-2013
Official wording
Reason: 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.
Code information: Product code: BC1440A; All lots manufactured after March 1, 2011
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Derived failure modes
-
Unknown
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.