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
Introducer, Catheter DYB
Electrosurgical, Cutting & Coagulation & Accessories GEI
Iliac Covered Stent, Arterial PRL
Catheter, Angioplasty, Peripheral, Transluminal LIT
Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access PQK
Stent, Iliac NIO
Catheter, Percutaneous DQY

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)