Solitaire 2 Revascularization Device

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

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 Solitaire 2 Revascularization Device.

Pre-market Notification Details

Device IDK162539
510k NumberK162539
Device Name:Solitaire 2 Revascularization Device
ClassificationNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Applicant MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine,  CA  92618
ContactJennifer Correa
CorrespondentJennifer Correa
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine,  CA  92618
Product CodePOL  
CFR Regulation Number882.5600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-12
Decision Date2016-11-10
Summary:summary

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