MICROPLEX COIL SYSTEM

Device, Neurovascular Embolization

MICROVENTION, INC.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Microplex Coil System.

Pre-market Notification Details

Device IDK012145
510k NumberK012145
Device Name:MICROPLEX COIL SYSTEM
ClassificationDevice, Neurovascular Embolization
Applicant MICROVENTION, INC. 72 ARGONAUT Aliso Viejo,  CA  92656
ContactVincent Cutarelli
CorrespondentVincent Cutarelli
MICROVENTION, INC. 72 ARGONAUT Aliso Viejo,  CA  92656
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-10
Decision Date2001-10-29
Summary:summary

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