Traxcess
Traxcess 7 Mini Guidewire is a catheter guidewire for general intravascular use, including the neurovascular and peripheral vasculature. It can be steered to help selectively place…
Traxcess 7 Mini Guidewire is a catheter guidewire for general intravascular use, including the neurovascular and peripheral vasculature. It can be steered to help selectively place diagnostic or therapeutic catheters.
The filing describes a coated stainless-steel core wire with a distal coil assembly. It also identifies shaping mandrels, an insertion tool and a torque device among the supplied items.
Listed Item
Traxcess 7 Mini
Coating and Use Limits
The summary says the hydrophilic coating provides lubricity as the guidewire passes through microcatheters. The stated indication excludes use in coronary arteries.
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 | MicroVention, Inc., United States |
|---|---|
| FDA product code | MOF |
| Device type | Guide, Wire, Catheter, Neurovasculature |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K201487 |
| Record published | 2025-04-30 |
| Record revised | 2026-04-28 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GW0721006M-AL | 0.014 inch x 210 cm | In distribution |
| GW1420040SK-AL | 0.014 inch x 200 cm | In distribution |
| GW1420040SK | 0.014 inch x 200 cm | 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 |
|---|---|
| K201487 | 2020-07-02 |
| K200547 | 2020-04-16 |
| K163154 | 2016-12-09 |
| K161803 | 2016-09-30 |
| K153053 | 2015-12-29 |
| K133725 | 2014-07-31 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-08-07 | Class II | Under Investigation by firm | There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire. | 34 units | 2018-10-26 |
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.