FDA Registration
Active
🇺🇸 United States
Inspira Air Balloon Dilation System
Reg #: 3005172759
·
FEI: 3005172759
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ACCLARENT, INC.
- Registration Number
- 3005172759
- FEI Number
- 3005172759
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 31 Technology Dr Suite 200
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090660
Owner / Operator
- Firm Name
- ACCLARENT, INC.
- Operator Number
- 9068915
- Address
- 31 TECHNOLOGY DRIVE, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2009-07-29 |
Proprietary Names
Inspira Air Balloon Dilation System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility