Cleared Special

K153053 - Traxcess Pro 14 Guidewire

K153053 is an FDA 510(k) clearance for Traxcess Pro 14 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 70-day FDA review.

K153053 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
70d
Days
Class 2
Risk

K153053 is an FDA 510(k) clearance for the Traxcess Pro 14 Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tustin, US). The FDA issued a Cleared decision on December 29, 2015 after a review of 70 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 - K153053

510(k) Number K153053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2015
Decision Date December 29, 2015
Days to Decision 70 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
79d faster than avg
Panel avg: 149d · This submission: 70d
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 K153053.
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
Viradius Neurowire
K151825 · Mivi Neuroscience, Inc. · Nov 2015
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
K141751 · Asahi Intecc Co., Ltd. · Jan 2015
TRAXCESS 14 GUIDEWIRE
K133725 · MicroVention, Inc. · Jul 2014
K153053 · Traxcess Pro 14 Guidewire
Download PDF FDA Summary MicroVention, Inc.