Hybrid Guidewire
Hybrid Guidewire is a steerable wire for selective placement of diagnostic or therapeutic catheters in neurovascular and peripheral vessels. It fits inside a compatible microcatheter and is…
Hybrid Guidewire is a steerable wire for selective placement of diagnostic or therapeutic catheters in neurovascular and peripheral vessels. It fits inside a compatible microcatheter and is not intended for coronary arteries.
The wire combines a proximal stainless steel core and distal nitinol core. A tapered distal tip is contained within a platinum-tungsten and stainless steel coil for radiographic visibility. Straight and curved tip designs are available.
Listed Item
HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnositc or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient’s tortuous anatomy.
Coatings and Accessories
Hydrophilic coating covers the coil and distal stainless steel section, while the proximal stainless steel section has a PTFE coating. These coatings provide lubricity during passage through microcatheters. A torquer and introducer are supplied with the guidewire.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Enlight Medical Technologies (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Balt USA, LLC, United States |
|---|---|
| FDA product code | MOF |
| Device type | Guide, Wire, Catheter, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K182337 |
| Record published | 2018-12-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a dry place at room temperature and away from light |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HYBRID014D | 0.014mm x 200cm | In distribution |
| HYBRID007J | 0.007mm x 220cm | In distribution |
| HYBRID12D300 | 0.012mm x 310cm | In distribution |
| HYBRID008J | 0.008mm x 220cm | In distribution |
| HYBRID1214D | 0.012mm x 200cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Willow 14 Guidewire | Arbor Endovascular | 22 |
| Cypress 14 Guidewire | Arbor Endovascular | 9 |
| Aristotle | Scientia Vascular | 8 |
| DCwire™ | Shanghai Achieva Medical Suzhou Co., Ltd. | 8 |
| Synchro Select | Stryker GmbH | 6 |
| Chikai Nexus 014 | Asahi Intecc Co., Ltd. | 6 |
| Chikai | Asahi Intecc Co., Ltd. | 4 |
| Volo | Scientia Vascular | 4 |
| Chikai black | Asahi Intecc Co., Ltd. | 4 |
| Chikai Nexus petit | Asahi Intecc Co., Ltd. | 3 |
| Agility | Cerenovus, Inc. | 3 |
| Traxcess | MicroVention, Inc. | 3 |
Showing 12 of 42. All products under Guide, Wire, Catheter, Neurovasculature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182337 | 2018-10-04 |
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.