AXIUM DETACHABLE COIL SYSTEM

Device, Neurovascular Embolization

MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Axium Detachable Coil System.

Pre-market Notification Details

Device IDK133310
510k NumberK133310
Device Name:AXIUM DETACHABLE COIL SYSTEM
ClassificationDevice, Neurovascular Embolization
Applicant MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine,  CA  92618
ContactAngela Lamprey
CorrespondentAngela Lamprey
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine,  CA  92618
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-28
Decision Date2014-01-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536017153 K133310 000
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00847536029408 K133310 000
00847536001879 K133310 000
00847536001886 K133310 000
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00847536001978 K133310 000
00847536001985 K133310 000
00847536001992 K133310 000
00847536002005 K133310 000
00847536002012 K133310 000
00847536037212 K133310 000

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