NEXIVA CLOSED IV CATHETER SYSTEM

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.

The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for Nexiva Closed Iv Catheter System.

Pre-market Notification Details

Device IDK032843
510k NumberK032843
Device Name:NEXIVA CLOSED IV CATHETER SYSTEM
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy,  UT  84070
ContactLeslie Wood
CorrespondentLeslie Wood
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy,  UT  84070
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-11
Decision Date2004-02-27
Summary:summary

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