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.
13manufacturers in China registered for this device type
49catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Clearstream Technologies Ltd., Ireland |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K192313 |
| Record published | 2020-04-27 |
| Record revised | 2024-01-23 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight; Special storage condition: Keep dry |
| Packaging | Case of 5 |
| Sizes | Length 10 to 90 cm |
| Distribution end date | 2024-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HLO41018F | Maximum guidewire [EN] = 0.018 inch (in) | In distribution |
| HLO61035F | Maximum guidewire [EN] = 0.035 inch (in) | In distribution |
| HLO51018FH | Maximum guidewire [EN] = 0.018 inch (in) | In distribution |
| HLO41035FH | Maximum guidewire [EN] = 0.035 inch (in) | In distribution |
| HLO42535H | Inner Diameter [EN] = 4 French (F) | In distribution |
| HLO62535H | Máximo de guía [ES] = 0.035 inch (in) | In distribution |
| HLO51035FH | Length 10 cm | In distribution |
| HLO61018FHK | Inner Diameter [EN] = 6 French (F) | In distribution |
| HLO62535HK | Maximum guidewire [EN] = 0.035 inch (in) | In distribution |
| HLO42535HK | Inner Diameter [EN] = 4 French (F) | In distribution |
| HLO41018FH | Length 10 cm | In distribution |
| HLO52535HK | Shaft Length [EN] = 25 centimetre (cm) | In distribution |
| HLO52535H | Diámetro interno [ES] = 5 French (F) | In distribution |
| HLO52518HK | Shaft Length [EN] = 25 centimetre (cm) | In distribution |
| HLO51018FHK | Maximum guidewire [EN] = 0.018 inch (in) | In distribution |
| HLO41035FHK | Maximum guidewire [EN] = 0.035 inch (in) | In distribution |
| HLO49035 | Máximo de guía [ES] = 0.035 inch (in) | In distribution |
| HLO51035F | Diámetro interno [ES] = 5 French (F) | In distribution |
| HLO67035 | Inner Diameter [EN] = 6 French (F) | In distribution |
| HLO41018FHK | Shaft Length [EN] = 10 centimetre (cm) | In distribution |
| HLO47035 | Length 70 cm | In distribution |
| HLO51035FHK | Inner Diameter [EN] = 5 French (F) | In distribution |
| HLO64535 | Inner Diameter [EN] = 6 French (F) | In distribution |
| HLO54535 | Maximum guidewire [EN] = 0.035 inch (in) | In distribution |
| HLO52535 | Maximum guidewire [EN] = 0.035 inch (in) | In distribution |
| HLO62518HK | Shaft Length [EN] = 25 centimetre (cm) | In distribution |
| HLO61035FH | Length 10 cm | In distribution |
| HLO69035 | Maximum Guidewire [EN] = 0.035 inch (in) | In distribution |
| HLO51018F | Maximum guidewire [EN] = 0.018 inch (in) | In distribution |
| HLO61035FHK | Maximum guidewire [EN] = 0.035 inch (in) | In distribution |
| HLO57035 | Máximo de guía [ES] = 0.035 inch (in) | In distribution |
| HLO62535 | Length 25 cm | In distribution |
| HLO44535 | Inner Diameter [EN] = 4 French (F) | In distribution |
| HLO59035 | Diámetro interno [ES] = 5 French (F) | In distribution |
| HLO42518HK | Inner Diameter [EN] = 4 French (F) | In distribution |
| HLO41035F | Length 10 cm | In distribution |
| HLO42535 | Diámetro interno [ES] = 4 French (F) | In distribution |
| HLO41018 | Withdrawn | |
| HLO61018FH | Inner diameter, 6F | Withdrawn |
| HLO62518H | Shaft length, 25cm | Withdrawn |
| HAL590 | Shaft Length, 90 centimeter | Withdrawn |
| HAL510F | Shaft Length, 10 centimeter | Withdrawn |
| HLO42518H | Shaft Length, 25cm | Withdrawn |
| HLO51035 | Withdrawn | |
| HAL545 | Inner Diameter, 5 French | Withdrawn |
| HLO41035 | Withdrawn | |
| HLO52518H | Shaft length, 25cm | Withdrawn |
| HLO51018 | Withdrawn | |
| HLO61035 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | UDI-DI | 2016-12-02 | Class I | Device Design | Complaints of sheath separation, kinking, and/or tip damage during use. | 101 units | 2017-04-05 |
| Bard Peripheral Vascular, Inc. | UDI-DI | 2016-12-02 | Class I | Device Design | Complaints of sheath separation, kinking, and/or tip damage during use. | 101 | 2017-04-05 |
| Bard Peripheral Vascular, Inc. | UDI-DI | 2016-12-02 | Class I | Device Design | Complaints of sheath separation, kinking, and/or tip damage during use. | 101 | 2017-04-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.