Traxcess 7 Mini Xsoft
Traxcess 7 Mini XSoft is a steerable guidewire that directs diagnostic or therapeutic microcatheters through neurovascular or peripheral vessels. It is not indicated for coronary arteries.…
Traxcess 7 Mini XSoft is a steerable guidewire that directs diagnostic or therapeutic microcatheters through neurovascular or peripheral vessels. It is not indicated for coronary arteries. A proximal stainless-steel core joins a distal nitinol core contained within a platinum-nickel coil.
The distal core tapers toward the tip, and the enclosing coil is 6 cm long. The physician can shape the distal 1.4 cm to assist catheter direction. Hydrophilic coatings on the proximal and distal sections provide lubricity during passage through a microcatheter.
Handling Accessories
The device includes a shaping mandrel, insertion tool and torque device. These accessories support preparation, introduction and steering of the wire. The XSoft version modifies the distal core-wire taper while retaining the basic guidewire design and intended vascular territories of the Mini range.
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) | K163154 |
| Record published | 2018-08-07 |
| Record revised | 2026-04-28 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GW0721006S | 0.014 inch x 210 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.