React 71 Catheter

Catheter, Percutaneous

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 React 71 Catheter.

Pre-market Notification Details

Device IDK182097
510k NumberK182097
Device Name:React 71 Catheter
ClassificationCatheter, Percutaneous
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 CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-03
Decision Date2018-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536031784 K182097 000
00847536044197 K182097 000

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