FDA Registration
Active
🇮🇪 Ireland
CLEARSTREAM TECHNOLOGIES LTD.
Reg #: 9616666
·
FEI: 3008906816
·
Expires 2026
Products
7
Proprietary Names
11
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- CLEARSTREAM TECHNOLOGIES LTD.
- Registration Number
- 9616666
- FEI Number
- 3008906816
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Moyne Upper, Enniscorthy
- City
- Wexford
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K212708
- PMA Number
- P160024
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 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-11-09 |
| Iliac Covered Stent, Arterial | PRL | Class 3 | Unknown | No | 2017-04-24 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2014-09-24 |
| Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | PQK | Class 2 | Cardiovascular | No | 2020-07-28 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2016-08-03 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2011-12-21 |
Proprietary Names
Halo One Thin-Walled Guiding Sheath
WavelinQ Generator
LifeStream Balloon Expandable Vascular Covered Stent
Ultraverse 035 PTA Balloon Dilatation Catheter
WavelinQ EndoAVF System
ESU-1 Electrosurgical Generator
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
Sleek OTW PTA Dilatation Catheter
Highlander 014 PTA Balloon Dilatation Catheter
Savvy Long and Sleek PTA Dilatation Catheter
Ultraverse RX PTA Balloon Dilatation Catheter
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)