Solitaire Platinum Revascularization Device, 6x40 Mm

Catheter, Thrombus Retriever

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 Platinum Revascularization Device, 6x40 Mm.

Pre-market Notification Details

Device IDK160641
510k NumberK160641
Device Name:Solitaire Platinum Revascularization Device, 6x40 Mm
ClassificationCatheter, Thrombus Retriever
Applicant Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
ContactRyan Kenney
CorrespondentJennifer Correa
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-07
Decision Date2017-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536033986 K160641 000
00847536020559 K160641 000

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