BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM

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

BECTON DICKINSON AND COMPANY (BD)

The following data is part of a premarket notification filed by Becton Dickinson And Company (bd) with the FDA for Bd Nexiva Diffusics Closed Iv Catheter System.

Pre-market Notification Details

Device IDK111366
510k NumberK111366
Device Name:BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BECTON DICKINSON AND COMPANY (BD) 9450 SOUTH STATE STREET Sandy,  UT  84070
ContactRachel Leblanc
CorrespondentRachel Leblanc
BECTON DICKINSON AND COMPANY (BD) 9450 SOUTH STATE STREET Sandy,  UT  84070
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-16
Decision Date2011-09-30
Summary:summary

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