Cleared Special

K163154 - Traxcess 7 Mini XSoft Guidewire

K163154 is an FDA 510(k) clearance for Traxcess 7 Mini XSoft Guidewire, manufactured by MicroVention, Inc.. The device is a Class 2 Neurology device with product code MOF cleared through the Special 510(k) pathway after a 29-day FDA review.

K163154 · MicroVention, Inc. · Neurology device
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Dec 2016
Decision
29d
Days
Class 2
Risk

K163154 is an FDA 510(k) clearance for the Traxcess 7 Mini XSoft Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on December 9, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1330 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all MicroVention, Inc. devices

FDA 510(k) Submission Details - K163154

510(k) Number K163154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2016
Decision Date December 09, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MOF Device Classification - Class 2, Special Controls

Product Code MOF Guide, Wire, Catheter, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - MOF Guide, Wire, Catheter, Neurovasculature

All 38
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