AIRWAY BALLOON CATHETER INFLATION DEVICE
FDA 510(k) clearance K090660 · decided 2009-06-12
Clearance details
- K-number
- K090660
- Device name
- AIRWAY BALLOON CATHETER INFLATION DEVICE
- Applicant
- Acclarent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-12
- Decision date
- 2009-06-12
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- KTI
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Rmenlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of ai recall (Z-1860-2013) | Acclarent, Inc. | 2013-08-01 |
| Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of ai recall (Z-1861-2013) | Acclarent, Inc. | 2013-08-01 |
| Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of a recall (Z-1862-2013) | Acclarent, Inc. | 2013-08-01 |
| Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of ai recall (Z-1863-2013) | Acclarent, Inc. | 2013-08-01 |
| Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of ai recall (Z-1864-2013) | Acclarent, Inc. | 2013-08-01 |
| Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of ai recall (Z-1865-2013) | Acclarent, Inc. | 2013-08-01 |
| Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of ai recall (Z-1866-2013) | Acclarent, Inc. | 2013-08-01 |