Cleared Special

K201690 - Mirage Hydrophilic Guidewire (FDA 510(k) Clearance)

Also includes:
X-pedion Hydrophilic Guidewire

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201690 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
29d
Days
Class 2
Risk

K201690 is an FDA 510(k) clearance for the Mirage 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 July 21, 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.

View all Micro Therapeutics, Inc. d/b/a ev3 Neurovascular devices

Submission Details

510(k) Number K201690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date July 21, 2020
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 762
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K201690.
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · FMD Co., Ltd. · Mar 2026
Enroute 0.014'' Transcarotid Guidewire
K253746 · Lake Region Medical · Mar 2026
EmeryGlide™ (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026