FDA Registration
Active
🇮🇪 Ireland
ITW-Filtertek
Reg #: 3004068971
·
FEI: 3004068971
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FILTERTEK, B.V. (AN ITW MEDICAL COMPANY)
- Registration Number
- 3004068971
- FEI Number
- 3004068971
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Industrial Estate
- City
- Newcastle West Limerick
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K150902
Owner / Operator
- Firm Name
- Filtertek, B.V. (An ITW Medical Company)
- Operator Number
- 10051079
- Address
- Industrial Estate
- City
- Newcastle West
- State
- Limerick
- Postal Code
- none
- Country
- IE
- Correspondent
- Neil Spillane
US Agent
- Business Name
- Coeur, Inc
- Contact Name
- Debra Manning
- Address
- 209 Creekside Dr
- City
- Washington
- State
- NC
- ZIP
- 27889
- Country
- US
- [email protected]
- Phone
- 615 5844193
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2018-01-15 |
Proprietary Names
ITW-Filtertek
Establishment Types
Manufacture Medical Device