FIRST MIDCATH 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 First Midcath Catheter.

Pre-market Notification Details

Device IDK972254
510k NumberK972254
Device Name:FIRST MIDCATH CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy,  UT  84070
ContactC.j. Welle
CorrespondentC.j. Welle
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 Received1997-06-16
Decision Date1997-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886333209815 K972254 000
20886333209808 K972254 000
20886333209792 K972254 000
20886333209785 K972254 000

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