BD Cathena (TM) Safety 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 Cathena (tm) Safety Iv Catheter.

Pre-market Notification Details

Device IDK192493
510k NumberK192493
Device Name:BD Cathena (TM) Safety 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
CorrespondentHenry Boland
Becton, Dickinson Infusion Therapy Systems, Inc. 9450 South State Street Sandy,  UT  84070
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-11
Decision Date2020-01-24

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