Devices

Device Recall Inspira AIR Balloon Dilation system

  • Model / Serial
    Product code: BC1040A; All lots manufactured after March 1, 2011
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
  • Product Description
    Inspira AIR Balloon Dilation system. || Size 10 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.
  • 1 Event

Manufacturer

Acclarent, Inc.
  • Manufacturer Address
    Acclarent, Inc., 1525-B O'Brien Dr, Menlo Park CA 94025-1463
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA

6 devices with a similar name

Learn more about the data here

Device Recall Inspira AIR Balloon Dilation system
  • Model / Serial
    Product code: BC1240A; All lots manufactured after March 1, 2011
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
  • Product Description
    Inspira AIR Balloon Dilation system. || Size 12 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.
Device Recall Inspira AIR Balloon Dilation system
  • Model / Serial
    Product code: BC1440A; All lots manufactured after March 1, 2011
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
  • Product Description
    Inspira AIR Balloon Dilation system. || Size 14 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.
Device Recall Inspira AIR Balloon Dilation system
  • Model / Serial
    Product code: BC1640A; All lots manufactured after March 1, 2011
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
  • Product Description
    Inspira AIR Balloon Dilation system. || Size 16 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.
Device Recall Inspira AIR Balloon Dilation system
  • Model / Serial
    Product code: BC0524A; All lots manufactured after March 1, 2011
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
  • Product Description
    Inspira AIR Balloon Dilation system. || Size 5 x 24 mm, Syringe volume 6-8 cc. || Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.
Device Recall Inspira AIR Balloon Dilation system
  • Model / Serial
    Product code: BC0724A; All lots manufactured after March 1, 2011
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
  • Product Description
    Inspira AIR Balloon Dilation system. || Size 7 x 24 mm, Syringe volume 6-8 cc. || Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.
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