Axium Detachable Coil; Axium Prime Detachable Coil

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; Axium Prime Detachable Coil.

Pre-market Notification Details

Device IDK203432
510k NumberK203432
Device Name:Axium Detachable Coil; Axium Prime Detachable Coil
ClassificationDevice, Neurovascular Embolization
Applicant Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 5290 California Ave Irvine,  CA  92617
ContactBhavika Patel
CorrespondentBhavika Patel
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 5290 California Ave Irvine,  CA  92617
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-23
Decision Date2021-07-07

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