FlowTriever Retrieval/Aspiration System

Peripheral Mechanical Thrombectomy With Aspiration

Inari Medical

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

Pre-market Notification Details

Device IDK202345
510k NumberK202345
Device Name:FlowTriever Retrieval/Aspiration System
ClassificationPeripheral Mechanical Thrombectomy With Aspiration
Applicant Inari Medical 9 Parker, Suite 100 Irvine,  CA  92618
ContactEben Gordon
CorrespondentEben Gordon
Inari Medical 9 Parker, Suite 100 Irvine,  CA  92618
Product CodeQEW  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-18
Decision Date2020-12-18

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