CLEARSTREAM TECHNOLOGIES LTD.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9616666	3008906816	CLEARSTREAM TECHNOLOGIES LTD.	1	N	2026-01-01	Moyne Upper Enniscorthy Wexford IE IRL

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00801741161810	Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of five	+1(908)277-8000	medical.services@crbard.com
00801741161810	Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of five	+1(800)321-4254	medical.services@crbard.com
00801741161810	Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of five	+353()539237111	ENN-Complaints@crbard.com

crbard.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
136607	1549833751	P160024	LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT	PRL	2017-04-24
136607	1916396666	K222793	WavelinQ™ Generator	GEI	2022-10-17
136607	1589819207	K212708	Halo One Thin-Walled Guiding Sheath	DYB	2021-09-23
136607	2039529392	K192313	Halo One Thin-Walled Guiding Sheath	DYB	2019-12-19
136607	1735491724	K192239	WavelinQ Plus EndoAVF System	PQK	2019-10-17
136607	1927278284	K191532	The Caterpillar and Caterpillar Micro Arterial Embolization Devices	KRD	2020-02-04
136607	1594950991	K162656	ESU-1 Electrosurgical Generator	GEI	2016-11-10
136607	1568444060	K130786	SLEEK OTW PTA CATHETER	LIT	2013-05-03
136607	1042359605	K102035	SLEEK OTW PTA CATHETERS	LIT	2010-12-01
136607	1384561573	K072947	SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS	LIT	2008-02-08
136607	1309968849
136607	1114778912
136607	1178139770
136607	1569668445
136607	1585242135
136607	1780749456
136607	1994752367

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LIT	3	2013-05-03
GEI	2	2022-10-17
DYB	2	2021-09-23
KRD	1	2020-02-04
PQK	1	2019-10-17
PRL	1	2017-04-24

PMN#

REEFLEX PTA CATHETER
2010-08-04
CLEARSTREAM TECHNOLOGIES, LTD.
REEKROSS FAMILY OR OTW PTA CATHETERS
2009-03-02
CLEARSTREAM TECHNOLOGIES, LTD.
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
2008-02-08
CLEARSTREAM TECHNOLOGIES, LTD.

GUDID#

Halo One™ Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 10 cm shaft length, including 035 Dilator Multipack of five
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of five
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of five
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of five
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of five
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter, 90 cm shaft length, including 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter, 45 cm shaft length, including 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 4F guiding sheath diameter, 90 cm shaft length, including 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 4F guiding sheath diameter, 70 cm shaft length, including 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 4F guiding sheath diameter, 45 cm shaft length, including 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 90cm shaft length, 0.035 dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2021-11-15
Halo One Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 70cm shaft length, 0.035 dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2021-11-15
Halo One Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 45cm shaft length, 0.035 dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2021-11-15
Halo One Thin-Walled Guiding Sheath - 6F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Kit
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 6F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including access kit.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 5F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including access kit.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 5F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including access kit.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including access kit.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including access kit.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One™ Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 25 cm shaft length, 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 4F guiding sheath diameter,25 cm shaft length, including 035 Dilator with hydrophilic coating
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One Thin-Walled Guiding Sheath - 6F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 6F guiding sheath diameter, 10cm shaft length, 0.035 dilator, hydrophilic coated, including access kit. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 5F guiding sheath diameter, 10cm shaft length, 0.035 dilator, hydrophilic coated, including access kit. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 5F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10cm shaft length, 0.035 dilator, hydrophilic coated, including access kit. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2021-12-14
Halo One™ Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic coating. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic coating. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter,10 cm shaft length, including 018 Dilator with hydrophilic coating. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 4F guiding sheath diameter,10 cm shaft length, including 035 Dilator with hydrophilic coating. Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 4F guiding sheath diameter,10 cm shaft length, including 018 Dilator with hydrophilic coating, Multipack of 5.
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
CLEARSTREAM TECHNOLOGIES LIMITED
2020-04-27
LifeStream - LifeStream™ Balloon Expandable Vascular Covered Stent, 8 mm x 16 mm, 135 cm catheter length
CLEARSTREAM TECHNOLOGIES LIMITED
2017-04-26
LifeStream - LifeStream™ Balloon Expandable Vascular Covered Stent, 8 mm x 16 mm, 80 cm catheter length
CLEARSTREAM TECHNOLOGIES LIMITED
2017-04-26
LifeStream - LifeStream™ Balloon Expandable Vascular Covered Stent, 7 mm x 16 mm, 135 cm catheter length
CLEARSTREAM TECHNOLOGIES LIMITED
2017-04-26

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