Traxcess 7 Mini Guidewire

Guide, Wire, Catheter, Neurovasculature

Micro Vention Inc.

The following data is part of a premarket notification filed by Micro Vention Inc. with the FDA for Traxcess 7 Mini Guidewire.

Pre-market Notification Details

Device IDK201487
510k NumberK201487
Device Name:Traxcess 7 Mini Guidewire
ClassificationGuide, Wire, Catheter, Neurovasculature
Applicant Micro Vention Inc. 35 Enterprise Aliso Viejo,  CA  92656
ContactGanesh Balachandar
CorrespondentGanesh Balachandar
Micro Vention Inc. 35 Enterprise Aliso Viejo,  CA  92656
Product CodeMOF  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-04
Decision Date2020-07-02

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