crbard.comREEFLEX PTA CATHETER
CLEARSTREAM TECHNOLOGIES, LTD.
CLEARSTREAM TECHNOLOGIES LTD.
FDA Registration(s)#
| 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#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00801741184802 | 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. | +353()539237111 | ENN-Complaints@crbard.com |
| 00801741184819 | 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. | +353()539237111 | ENN-Complaints@crbard.com |
| 00801741184833 | 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. | +353()539237111 | ENN-Complaints@crbard.com |
| 00801741184840 | 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. | +353()539237111 | ENN-Complaints@crbard.com |
| 00801741184864 | 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. | +353()539237111 | ENN-Complaints@crbard.com |
| 00801741223778 | Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Multipack of 5. | +353()539237111 | ENN-Complaints@crbard.com |
| 00801741223785 | Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10cm shaft length, 0.035 dilator, hydrophilic coated, including access kit. Multipack of 5. | +353()539237111 | ENN-Complaints@crbard.com |
| 00801741223815 | Halo One Thin-Walled Guiding Sheath - 5F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Multipack of 5. | +353()539237111 | ENN-Complaints@crbard.com |
Registered Device Listings#
| 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#
PMN#
REEKROSS FAMILY OR OTW PTA CATHETERS
CLEARSTREAM TECHNOLOGIES, LTD.
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
CLEARSTREAM TECHNOLOGIES, LTD.
GUDID#
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.
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.
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.
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.
2020-04-27
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.
2020-04-27
Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Multipack of 5.
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.
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.
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.
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.
2021-12-14
Halo One Thin-Walled Guiding Sheath - 6F guiding sheath diameter, 10cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Multipack of 5.
2021-12-14
Halo One™ Thin-Walled Guiding Sheath - Halo One 4F guiding sheath diameter,25 cm shaft length, including 035 Dilator with hydrophilic coating
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
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 25 cm shaft length, 035 Dilator with hydrophilic coating
2020-04-27
Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including access kit.
2021-12-14
Halo One Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including access kit.
2021-12-14
Halo One Thin-Walled Guiding Sheath - 5F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including access kit.
2021-12-14
Halo One Thin-Walled Guiding Sheath - 5F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including access kit.
2021-12-14
Halo One Thin-Walled Guiding Sheath - 6F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including access kit.
2021-12-14
Halo One Thin-Walled Guiding Sheath - 6F guiding sheath diameter, 25cm shaft length, 0.018 dilator, hydrophilic coated, including access kit. Kit
2021-12-14
Halo One Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 45cm shaft length, 0.035 dilator with hydrophilic coating
2021-11-15
Halo One Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 70cm shaft length, 0.035 dilator with hydrophilic coating
2021-11-15
Halo One Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 90cm shaft length, 0.035 dilator with hydrophilic coating
2021-11-15
Halo One™ Thin-Walled Guiding Sheath - Halo One 4F guiding sheath diameter, 45 cm shaft length, including 035 Dilator with hydrophilic coating
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
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
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 5F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
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
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
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
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10 cm shaft length, including 018 Dilator, Multipack of five
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of five
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
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
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - Halo One 6F guiding sheath diameter, 10 cm shaft length, including 035 Dilator Multipack of five
2020-04-27
Halo One™ Thin-Walled Guiding Sheath - 4F guiding sheath diameter, 25 cm shaft length, including 035 Dilator
2020-04-27
LifeStream - LifeStream™ Balloon Expandable Vascular Covered Stent, 5 mm x 26 mm, 80 cm catheter length
2017-04-27
LifeStream - LifeStream™ Balloon Expandable Vascular Covered Stent, 5 mm x 37 mm, 80 cm catheter length
2017-04-26
LifeStream - LifeStream™ Balloon Expandable Vascular Covered Stent, 5 mm x 26 mm, 135 cm catheter length
2017-04-26