ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath

Catheter, Embolectomy

Inari Medical

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

Pre-market Notification Details

Device IDK173470
510k NumberK173470
Device Name:ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-08
Decision Date2017-12-04
Summary:summary

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