BD Angiocath IV Catheter, BD Insyte IV Catheter

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 Angiocath Iv Catheter, Bd Insyte Iv Catheter.

Pre-market Notification Details

Device IDK151698
510k NumberK151698
Device Name:BD Angiocath IV Catheter, BD Insyte IV Catheter
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE STREET Sandy,  UT  84070
ContactHenry Boland
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2015-06-24
Decision Date2015-07-27
Summary:summary

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