Solitaire 4 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 4 Revascularization Device.

Pre-market Notification Details

Device IDK183022
510k NumberK183022
Device Name:Solitaire 4 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
ContactHelen Chow
CorrespondentHelen Chow
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 Received2018-11-01
Decision Date2019-01-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000425739 K183022 000
00763000425715 K183022 000
00763000425692 K183022 000
00763000425678 K183022 000
00763000425654 K183022 000
00763000425630 K183022 000

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