ClotTriever Thrombectomy System

Catheter, Embolectomy

Inari Medical

The following data is part of a premarket notification filed by Inari Medical with the FDA for Clottriever Thrombectomy System.

Pre-market Notification Details

Device IDK182531
510k NumberK182531
Device Name:ClotTriever Thrombectomy System
ClassificationCatheter, Embolectomy
Applicant Inari Medical 9272 Jeronimo Road Suite 124 Irvine,  CA  92618
ContactEben Gordon
CorrespondentEben Gordon
Inari Medical 9272 Jeronimo Road Suite 124 Irvine,  CA  92618
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-14
Decision Date2018-10-10
Summary:summary

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