Devices

Device Recall Airway balloon catheter

  • Model / Serial
    Product code BC1840A, Size 18 x 40: Lot 110307E, Exp 3/2013; Lot 110429E, Exp 4/2013; Lot 110502B, Exp 5/2013; Lot 110506B, Exp 5/2013; Lot 110606B, Exp 6/2013; Lot 110614B, Exp 6/2013.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, Saudi Arabia
  • Product Description
    Inspira AIR Balloon Dilation System, || size 18 x 40; || Manufactured by Acclarent, Inc. || 1525-G O'Brien Drive, Menlo Park, CA 94025 || Product Usage: Dilation of airway tree.
  • Manufacturer
    Acclarent, Inc.
  • 1 Event

Manufacturer

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