FlowTriever Catheter, 6-10 Mm; FlowTreiver Catheter, 11-14 Mm; FlowTreiver Catheter, 15-18 Mm; Aspiration Guide Catheter; Retraction Aspirator

Catheter, Embolectomy

Inari Medical

The following data is part of a premarket notification filed by Inari Medical with the FDA for Flowtriever Catheter, 6-10 Mm; Flowtreiver Catheter, 11-14 Mm; Flowtreiver Catheter, 15-18 Mm; Aspiration Guide Catheter; Retraction Aspirator.

Pre-market Notification Details

Device IDK180466
510k NumberK180466
Device Name:FlowTriever Catheter, 6-10 Mm; FlowTreiver Catheter, 11-14 Mm; FlowTreiver Catheter, 15-18 Mm; Aspiration Guide Catheter; Retraction Aspirator
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-21
Decision Date2018-05-17
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.