AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415

Device, Neurovascular Embolization

MICROVENTION, INC.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415.

Pre-market Notification Details

Device IDK090168
510k NumberK090168
Device Name:AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
ClassificationDevice, Neurovascular Embolization
Applicant MICROVENTION, INC. 75 COLUMBIA Aliso Viejo,  CA  92656 -1408
ContactFlorin Truuvert
CorrespondentFlorin Truuvert
MICROVENTION, INC. 75 COLUMBIA Aliso Viejo,  CA  92656 -1408
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-23
Decision Date2009-03-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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