Infusion Aspiration Catheter System

Catheter, Embolectomy

Inari Medical, Inc.

The following data is part of a premarket notification filed by Inari Medical, Inc. with the FDA for Infusion Aspiration Catheter System.

Pre-market Notification Details

Device IDK143563
510k NumberK143563
Device Name:Infusion Aspiration Catheter System
ClassificationCatheter, Embolectomy
Applicant Inari Medical, Inc. 8 Argonaut Suite 100 Aliso Vejo,  CA  92656
ContactEben Gordon
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2014-12-16
Decision Date2015-02-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850291007062 K143563 000
00850291007055 K143563 000
00850291007048 K143563 000
00850291007031 K143563 000
00850291007024 K143563 000
00850291007017 K143563 000
00850291007000 K143563 000

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