CONCERTO DETACHABLE COIL SYSTEM

Device, Vascular, For Promoting Embolization

MICRO THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Concerto Detachable Coil System.

Pre-market Notification Details

Device IDK090046
510k NumberK090046
Device Name:CONCERTO DETACHABLE COIL SYSTEM
ClassificationDevice, Vascular, For Promoting Embolization
Applicant MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine,  CA  92618
ContactNeelu Medhekar
CorrespondentNeelu Medhekar
MICRO THERAPEUTICS, INC. 9775 TOLEDO WAY Irvine,  CA  92618
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-07
Decision Date2009-02-27
Summary:summary

NIH GUDID Devices

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