BD 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 Bd Nexiva Closed Iv Catheter System.

Pre-market Notification Details

Device IDK102520
510k NumberK102520
Device Name:BD 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
ContactJustice Alder
CorrespondentJustice Alder
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy,  UT  84070
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-02
Decision Date2011-01-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903835404 K102520 000
50382903835114 K102520 000
50382903835121 K102520 000
50382903835169 K102520 000
50382903835176 K102520 000
50382903835183 K102520 000
50382903835190 K102520 000
50382903835206 K102520 000
50382903835305 K102520 000
50382903835312 K102520 000
50382903835329 K102520 000
50382903835367 K102520 000
50382903835374 K102520 000
50382903835381 K102520 000
50382903835398 K102520 000
50382903835107 K102520 000

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