FDA Registration
Active
🇺🇸 United States
Argyle Peritoneal Dialysis Catheter
Reg #: 1282497
·
FEI: 1282497
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Covidien LLC
- Registration Number
- 1282497
- FEI Number
- 1282497
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 15 HAMPSHIRE STREET
- City
- MANSFIELD
- State
- MA
- ZIP
- 02048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K890288
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
- Correspondent
- Tania Pearson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Peritoneal, Long-Term Indwelling | FJS | Class 2 | Gastroenterology, Urology | No | 2008-01-17 |
Proprietary Names
Argyle Peritoneal Dialysis Catheter
Argyle Peritoneal Dialysis Catheter Stencil
Argyle Neonatal Peritoneal Dialysis Catheter
Argyle Peritoneal Dialysis Catheter Kit
Argyle Pediatric Peritoneal Dialysis Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility