MICROPLEX COIL SYSTEMS (MCS)

Device, Neurovascular Embolization

MICROVENTION, INC.

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

Pre-market Notification Details

Device IDK021914
510k NumberK021914
Device Name:MICROPLEX COIL SYSTEMS (MCS)
ClassificationDevice, Neurovascular Embolization
Applicant MICROVENTION, INC. 72 ARGONAUT Aliso Viejo,  CA  92656 -1408
ContactVincent Cutarelli
CorrespondentVincent Cutarelli
MICROVENTION, INC. 72 ARGONAUT Aliso Viejo,  CA  92656 -1408
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-11
Decision Date2002-07-09
Summary:summary

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