FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24

Peripheral Mechanical Thrombectomy With Aspiration

Inari Medical, Inc.

The following data is part of a premarket notification filed by Inari Medical, Inc. with the FDA for Flowtriever Retrieval/aspiration System, Flowtriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24.

Pre-market Notification Details

Device IDK211013
510k NumberK211013
Device Name:FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
ClassificationPeripheral Mechanical Thrombectomy With Aspiration
Applicant Inari Medical, Inc. 9 Parker, Suite 100 Irvine,  CA  92618
ContactLarry Boucher
CorrespondentLarry Boucher
Inari Medical, Inc. 9 Parker, Suite 100 Irvine,  CA  92618
Product CodeQEW  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-05
Decision Date2021-04-30

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