Solitaire Platinum Revascularization Device

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.

Pre-market Notification Details

Device IDK161879
510k NumberK161879
Device Name:Solitaire Platinum Revascularization Device
ClassificationCatheter, Thrombus Retriever
Applicant Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
ContactRyan Kenney
CorrespondentRyan Kenney
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-08
Decision Date2016-09-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536033979 K161879 000
00847536033962 K161879 000
00847536027060 K161879 000
00847536027053 K161879 000

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