FDA Registration
Active
🇮🇪 Ireland
Halo One Thin-Walled Guiding Sheath
Reg #: 9616666
·
FEI: 3008906816
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CLEARSTREAM TECHNOLOGIES LTD.
- Registration Number
- 9616666
- FEI Number
- 3008906816
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Moyne Upper, Enniscorthy
- City
- Wexford
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K212708
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2021-11-10 |
Proprietary Names
Halo One Thin-Walled Guiding Sheath
Establishment Types
Manufacture Medical Device