FDA Registration
Active
🇨🇷 Costa Rica
Next Generation Balloon Dilation System
Reg #: 3009018440
·
FEI: 3009018440
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Nitinol Devices & Components Costa Rica, S. R. L.
- Registration Number
- 3009018440
- FEI Number
- 3009018440
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Coyol Free Zone, Building B14, B15, B25, B28
- City
- El Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K201115
Owner / Operator
- Firm Name
- Confluent Medical Technologies, Inc.
- Operator Number
- 10033958
- Address
- 6263 N. Scottsdale Road, Suite 224
- City
- Scottsdale
- State
- AZ
- Postal Code
- 85250
- Country
- US
- Correspondent
- Rich Brown
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Eustachian Tube Balloon Dilation Device | PNZ | Class 2 | Ear, Nose, Throat | No | 2021-02-15 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2021-02-15 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2021-02-15 |
Proprietary Names
Next Generation Balloon Dilation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)