FDA Registration
Active
🇮🇪 Ireland
Infusion Catheter
Reg #: 8020889
·
FEI: 3003382061
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Mallinckrodt Medical
- Registration Number
- 8020889
- FEI Number
- 3003382061
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CORNAMADDY
- City
- ATHLONE Westmeath
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K940634
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
- Medtronic formerly Covidien
- Contact Name
- Kae Miller
- Address
- 6165 Gunbarrel Ave
- City
- Boulder
- State
- CO
- ZIP
- 80301
- Country
- US
- [email protected]
- Phone
- 303 4081427
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2015-11-10 |
Proprietary Names
Infusion Catheter
Cragg-McNamara Valved Infusion Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Repack or Relabel Medical Device