Data / Medical devices / Ireland / Clearstream Technologies Ltd.
Clearstream Technologies Ltd.: FDA-registered device maker in Wexford, Ireland, 8 510(k) clearances and 1 PMA approval
Clearstream Technologies Ltd. is registered with the FDA (registration 9616666) in Wexford, Ireland. It lists 7 device types. The FDA files 8 510(k) clearances and 1 PMA approval under its listings, the newest dated October 17, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616666
- FEI number
- 3008906816
- Address
- Moyne Upper Enniscorthy, Wexford, Ireland, IRL
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 21, 2011
- Registered through
- 2027
- Brand names listed
- ESU-1 Electrosurgical Generator, Halo One Thin-Walled Guiding Sheath, Highlander 014 PTA Balloon Dilatation Catheter, LifeStream Balloon Expandable Vascular Covered Stent, Savvy Long and Sleek PTA Dilatation Catheter, Sleek OTW PTA Dilatation Catheter, Ultraverse 014 and 018 PTA Balloon Dilatation Catheters, Ultraverse 035 PTA Balloon Dilatation Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Iliac Covered Stent, Arterial | PRL | 3 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | PQK | 2 | Manufacturer | accessdata.fda.gov |
| Stent, Iliac | NIO | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2022 | K222793 | WavelinQ Generator | GEI | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 23, 2021 | K212708 | Halo One Thin-Walled Guiding Sheath | DYB | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 19, 2019 | K192313 | Halo One Thin-Walled Guiding Sheath | DYB | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 17, 2019 | K192239 | WavelinQ Plus EndoAVF System | PQK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 10, 2016 | K162656 | ESU-1 Electrosurgical Generator | GEI | Substantially Equivalent | Tva Medical, Inc. | accessdata.fda.gov |
| May 3, 2013 | K130786 | SLEEK OTW PTA CATHETER | LIT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 1, 2010 | K102035 | SLEEK OTW PTA CATHETERS | LIT | Substantially Equivalent | ClearStream Technologies , Ltd. | accessdata.fda.gov |
| February 8, 2008 | K072947 | SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS | LIT | Substantially Equivalent | ClearStream Technologies , Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 24, 2017 | P160024 | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT | PRL | 14 | September 29, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheter, Percutaneous
- All makers of Iliac Covered Stent, Arterial
- All makers of Introducer, Catheter
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Stent, Iliac
Updated September 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.