FDA Registration
Active
🇺🇸 United States
Low Pressure Injection Extension Tu
Reg #: 1038185
·
FEI: 1038185
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- COEUR, INC.(A WHOLLY OWNED SUBSIDIARY OF ILLINOIS TOOL WORKS INC.)
- Registration Number
- 1038185
- FEI Number
- 1038185
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 209 Creekside Dr
- City
- WASHINGTON
- State
- NC
- ZIP
- 27889
- Country
- US
Regulatory Submissions
- 510(k) Number
- K942381
Owner / Operator
- Firm Name
- Coeur, Inc. (a wholly owned subsidiary of Illinois Tool Work
- Operator Number
- 9038672
- Address
- 209 Creekside Drive
- City
- Washington
- State
- NC
- Postal Code
- 27889
- Country
- US
- Correspondent
- NEIL F SPILLANE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2008-01-11 |
Proprietary Names
Low Pressure Injection Extension Tu
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)