Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616666

FEI Number

3008906816

Entity Name

CLEARSTREAM TECHNOLOGIES LTD.

City/State/Country

Wexford, IE

Establishment Address

Moyne Upper, Enniscorthy, Wexford IRL, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

C. R. Bard, Inc. (Owner Number: 2212754)

Owner / Operator Contact Address

1 Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192313

PMA Number

N/A

All Registered 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 WavelinQ EndoAVF System Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Halo One Thin-Walled Guiding Sheath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2021-11-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-11-09
PRL	Iliac Covered Stent, Arterial	Unknown	Class 3	N/A	2017-04-24
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-09-24
PQK	Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access	Cardiovascular	Class 2	870.1252	2020-07-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-04-03
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-09-27
PQK	Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access	Cardiovascular	Class 2	870.1252	2019-11-05
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2019-10-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-01-14

Official Correspondent

No official correspondent registered.

US Agent Details

Joni Anderson Email: joni.anderson@bd.com Phone: (480) 2662981

Related Public Records

Same Entity

C. R. Bard, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1725056	MEDIVANCE, INC.	LOUISVILLE, CO, US
3006513822	Lutonix, Inc.	Tempe, AZ, US
1223089	DAVOL INC.	WOBURN, MA, US
3002504068	Bard European Distribution Center NV	Olen Antwerpen, BE
1213643	DAVOL INC., SUB. C.R. BARD, INC.	Warwick, RI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0024-2025	Atrium Medical Corporation	3	iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Similar Registrations

Registration Number	Establishment Name	Location
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3041086754	PULNOVO MEDICAL (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616666. Last updated year: 2026. Please use registration number 9616666 when referencing this establishment in official correspondence.