WaveSelect
The listed WaveSelect record includes model GW1410, identified in the filing as a Synxess Neurovascular Guidewire with a 0.014-inch proximal diameter. The guidewire is intended for…
The listed WaveSelect record includes model GW1410, identified in the filing as a Synxess Neurovascular Guidewire with a 0.014-inch proximal diameter.
The guidewire is intended for neurovascular use to facilitate placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy.
Device Construction
The guidewire contains a core wire, coils and coatings. Its straight distal tip is shapeable, and it is supplied with a shaping mandrel and torque device.
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 | Enlight Medical Technologies (Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | MOF |
| Device type | Guide, Wire, Catheter, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Manufacturer |
| 510(k) | K240871 |
| Record published | 2025-07-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GW1410 | In distribution | |
| GW1010 | 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 |
| Hybrid Guidewire | Balt USA, LLC | 5 |
| 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 |
Showing 12 of 42. All products under Guide, Wire, Catheter, Neurovasculature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240871 | 2024-11-18 |
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.