FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter

Catheter, Embolectomy

Inari Medical

The following data is part of a premarket notification filed by Inari Medical with the FDA for Flowtriever Retrieval/aspiration System, Aspiration Guide Catheter.

Pre-market Notification Details

Device IDK173672
510k NumberK173672
Device Name:FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter
ClassificationCatheter, Embolectomy
Applicant Inari Medical 9272 Jeronimo Rd., Suite 124 Irvine,  CA  92618
ContactEben Gordon
CorrespondentEben Gordon
Inari Medical 9272 Jeronimo Rd., Suite 124 Irvine,  CA  92618
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-30
Decision Date2018-02-05
Summary:summary

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