FDA Registration
Active
🇺🇸 United States
Atlas Gold PTA Dilation Catheter
Reg #: 1646831
·
FEI: 1000160215
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIOMERICS FMI
- Registration Number
- 1646831
- FEI Number
- 1000160215
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1605/1704/1700 Enterprise St.
- City
- Athens
- State
- TX
- ZIP
- 75751
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212588
Owner / Operator
- Firm Name
- Biomerics FMI
- Operator Number
- 9008904
- Address
- 1605/1704/1700 ENTERPRISE ST., --
- City
- Athens
- State
- TX
- Postal Code
- 75751
- Country
- US
- Correspondent
- STACEY - LYONS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | Class 2 | Cardiovascular | No | 2022-05-10 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2022-05-10 |
| Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | OMZ | Class 2 | Cardiovascular | No | 2022-05-10 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2022-05-10 |
Proprietary Names
Atlas Gold PTA Dilation Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)