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Devices
Device Recall Inspira AIR Balloon Dilation system
Modelo / Serial
Product code: BC8524A; All lots manufactured after March 1, 2011
Clasificación del producto
Ear, Nose, and Throat Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Descripción del producto
Inspira AIR Balloon Dilation system. || Size 8.5 x 24 mm, Syringe volume 12 cc. || Dilation of airway tree.
Manufacturer
Acclarent, Inc.
1 Event
Retiro De Equipo (Recall) de Device Recall Inspira AIR Balloon Dilation system
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Fabricante
Acclarent, Inc.
Dirección del fabricante
Acclarent, Inc., 1525-B O'Brien Dr, Menlo Park CA 94025-1463
Empresa matriz del fabricante (2017)
Johnson & Johnson
Source
USFDA
6 dispositivos con un nombre similar
Más información acerca de la data
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Device Recall Inspira AIR Balloon Dilation system
Modelo / Serial
Product code: BC1040A; All lots manufactured after March 1, 2011
Clasificación del producto
Ear, Nose, and Throat Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Descripción del producto
Inspira AIR Balloon Dilation system. || Size 10 x 40 mm, Syringe volume 12 cc. || Dilation of airway tree.
Manufacturer
Acclarent, Inc.
Device Recall Inspira AIR Balloon Dilation system
Modelo / Serial
Product code: BC1240A; All lots manufactured after March 1, 2011
Clasificación del producto
Ear, Nose, and Throat Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Descripción del producto
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
Modelo / Serial
Product code: BC1440A; All lots manufactured after March 1, 2011
Clasificación del producto
Ear, Nose, and Throat Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Descripción del producto
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
Modelo / Serial
Product code: BC1640A; All lots manufactured after March 1, 2011
Clasificación del producto
Ear, Nose, and Throat Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Descripción del producto
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
Modelo / Serial
Product code: BC0524A; All lots manufactured after March 1, 2011
Clasificación del producto
Ear, Nose, and Throat Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Descripción del producto
Inspira AIR Balloon Dilation system. || Size 5 x 24 mm, Syringe volume 6-8 cc. || Dilation of airway tree.
Manufacturer
Acclarent, Inc.
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