Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire

Wire, Guide, Catheter

Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire.

Pre-market Notification Details

Device IDK193548
510k NumberK193548
Device Name:Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
ClassificationWire, Guide, Catheter
Applicant Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
ContactRyan Kenney
CorrespondentRyan Kenney
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelNeurology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-01-18

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