Apiration Guide Catheter ; FlowTriever Catheter

Catheter, Embolectomy

Inari Medical

The following data is part of a premarket notification filed by Inari Medical with the FDA for Apiration Guide Catheter ; Flowtriever Catheter.

Pre-market Notification Details

Device IDK182233
510k NumberK182233
Device Name:Apiration Guide Catheter ; FlowTriever 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-17
Decision Date2018-10-15
Summary:summary

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