FDA Registration
Active
🇨🇳 China
Navien Intracranial Support Catheter
Reg #: 3006451981
·
FEI: 3006451981
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Covidien Medical Products (Shanghai) Manufacturing LLC
- Registration Number
- 3006451981
- FEI Number
- 3006451981
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building #10, 1st Floor of Building #6, 2nd Floor of Building #15, 789 Puxing Road, 201114, Peoples Republic of China
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K110055
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
US Agent
- Business Name
- COVIDIEN
- Contact Name
- Dawn Tindall
- Address
- 200 Medtronic Dr
- City
- Lafayette
- State
- CO
- ZIP
- 80026
- Country
- US
- [email protected]
- Phone
- 303 5817034
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2025-03-05 |
Proprietary Names
Navien Intracranial Support Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)