FDA Registration
Active
🇺🇸 United States
Protek Venous Dilator set
Reg #: 1718850
·
FEI: 1718850
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- LivaNova USA, INC.
- Registration Number
- 1718850
- FEI Number
- 1718850
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 14401 WEST 65TH WAY
- City
- ARVADA
- State
- CO
- ZIP
- 80004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162181
Owner / Operator
- Firm Name
- LivaNova
- Operator Number
- 9003795
- Address
- 14401 W 65th Way
- City
- Arvada
- State
- CO
- Postal Code
- 80004
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2024-07-10 |
Proprietary Names
Protek Venous Dilator set
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)