Cleared Special

K193548 - Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire

K193548 is an FDA 510(k) clearance for Mirage Hydrophilic Guidewire, manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The device is a Class 2 Neurology device with product code DQX cleared through the Special 510(k) pathway after a 29-day FDA review.

K193548 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
29d
Days
Class 2
Risk

K193548 is an FDA 510(k) clearance for the Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on January 18, 2020 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 - K193548

510(k) Number K193548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date January 18, 2020
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.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
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 - DQX Wire, Guide, Catheter

All 755
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K193548.
Go2Wire Guide Wire
K193571 · Merit Medical System, Inc. · Apr 2020
HI-TORQUE Steelcore Bare Guide Wire
K200144 · Abbott Vascular · Apr 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
K192886 · Volcano Corporation · Mar 2020
Wattson Temporary Pacing Guidewire
K192454 · Vascular Solutions · Jan 2020
OptoWire III
K191907 · Opsens, Inc. · Jan 2020
ASAHI PTCA Guide Wire ASAHI Gaia Next
K192599 · Asahi Intecc Co., Ltd. · Jan 2020
K193548 · Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
Download PDF FDA Summary Micro Therapeutics, I…