AZUR Vascular Plug

Device, Vascular, For Promoting Embolization

MicroVention Inc.

The following data is part of a premarket notification filed by Microvention Inc. with the FDA for Azur Vascular Plug.

Pre-market Notification Details

Device IDK191680
510k NumberK191680
Device Name:AZUR Vascular Plug
ClassificationDevice, Vascular, For Promoting Embolization
Applicant MicroVention Inc. 35 Enterprise Aliso Viejo,  CA  92656
ContactGanesh Balachander
CorrespondentGanesh Balachander
MicroVention Inc. 35 Enterprise Aliso Viejo,  CA  92656
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-24
Decision Date2020-03-20

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