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Traxcess 7 Mini XSoft Guidewire

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163154

by Microvention Inc.

Identifiers

510(k) Number
K163154 FDA 510(k)
FDA Product Code
MOF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1330 FDA 510(k)
Regulation Number
870.1330 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Traxcess 7 Mini XSoft Guidewire is a low-profile, highly trackable guidewire with a distinct 0.007" to 0.014" tapered design, used to navigate microcatheters to hard-to-reach, distal vessels with precision. It is indicated for general intravascular use, including the neuro and peripheral vasculature, and can be steered to facilitate the selective placement of diagnostic or therapeutic catheters.

This device is not indicated for use in coronary arteries. It is supplied as a single-use device and requires appropriate storage conditions. The Traxcess 7 Mini XSoft Guidewire has received FDA 510(k) clearance with the product code MOF and is classified as a Class II device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Traxcess 7 MINI - assets.ctfassets.net, Traxcess™ Mini | Terumo Neuro - MicroVention, Traxcess 7 Mini XSoft Guidewire (K163154) — FDA 510(k) | Innolitics, Traxcess 7 Mini XSoft Guidewire (K163154) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Microvention Inc.
FDA Applicant
MicroVention, Inc.

Sources (1)

  • FDA 510(k) K163154 24 fields · synced Sep 27, 2026