Concerto Versa, Detachable Coil

Device, Vascular, For Promoting 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 Concerto Versa, Detachable Coil.

Pre-market Notification Details

Device IDK202850
510k NumberK202850
Device Name:Concerto Versa, Detachable Coil
ClassificationDevice, Vascular, For Promoting Embolization
Applicant Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
ContactRita De Rama
CorrespondentRita De Rama
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
Product CodeKRD  
CFR Regulation Number870.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-02-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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