Cleared Special

K200547 - Traxcess 14 SELECT Guidewire

K200547 is the FDA 510(k) clearance for Traxcess 14 SELECT Guidewire by MicroVention, Inc.. It is a Class 2 Neurology device (product code MOF) cleared through the Special 510(k) pathway after a 44-day FDA review.

K200547 · MicroVention, Inc. · Neurology device
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Apr 2020
Decision
44d
Days
Class 2
Risk

K200547 is an FDA 510(k) clearance for the Traxcess 14 SELECT Guidewire. Classified as Guide, Wire, Catheter, Neurovasculature (product code MOF), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 16, 2020 after a review of 44 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

Submission Details

510(k) Number K200547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date April 16, 2020
Days to Decision 44 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
104d faster than avg
Panel avg: 148d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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
Devices cleared under the same product code (MOF) and FDA review panel - the closest regulatory comparables to K200547.
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