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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
120d faster than avg
Panel avg: 149d · 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 44
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K163154.
HYBRID Guidewire
K182337 · Balt USA, LLC · Oct 2018
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
K181828 · Scientia Vascular, LLC · Aug 2018
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
K171613 · Asahi Intecc Co., Ltd. · Jul 2017
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
K161912 · Asahi Intecc Co., Ltd. · Oct 2016
Traxcess .007 Mini Guidewire
K161803 · MicroVention, Inc. · Sep 2016
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
K160659 · Asahi Intecc Co., Ltd. · Apr 2016