Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

Set, Administration, Intravascular

Ivenix, Inc.

The following data is part of a premarket notification filed by Ivenix, Inc. with the FDA for Ivenix Infusion System, Lvp Epidural Administraion Set Nrfit Connector.

Pre-market Notification Details

Device IDK213089
510k NumberK213089
Device Name:Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
ClassificationSet, Administration, Intravascular
Applicant Ivenix, Inc. 50 High St North Andover,  MA  01845
ContactJohn Sokolowski
CorrespondentJohn Sokolowski
Ivenix, Inc. 50 High St North Andover,  MA  01845
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-24
Decision Date2021-11-10

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