FDA Registration
Active
🇺🇸 United States
AFX Introducer System
Reg #: 3011063223
·
FEI: 3011063223
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Endologix LLC
- Registration Number
- 3011063223
- FEI Number
- 3011063223
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Musick
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120212
Owner / Operator
- Firm Name
- Endologix LLC
- Operator Number
- 9034802
- Address
- 2 MUSICK
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Kathryn Simpson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2012-04-18 |
Proprietary Names
AFX Introducer System
Establishment Types
Manufacture Medical Device