Cleared Special

K161803 - Traxcess .007 Mini Guidewire

K161803 is an FDA 510(k) clearance for Traxcess .007 Mini 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 92-day FDA review.

K161803 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
92d
Days
Class 2
Risk

K161803 is an FDA 510(k) clearance for the Traxcess .007 Mini 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 September 30, 2016 after a review of 92 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K161803

510(k) Number K161803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2016
Decision Date September 30, 2016
Days to Decision 92 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
57d faster than avg
Panel avg: 149d · This submission: 92d
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 K161803.
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K160659 · Asahi Intecc Co., Ltd. · Apr 2016
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K153053 · MicroVention, Inc. · Dec 2015
Viradius Neurowire
K151825 · Mivi Neuroscience, Inc. · Nov 2015