BD FlowSmart Set

Set, Administration, Intravascular

BECTON, DICKINSON COMPANY

The following data is part of a premarket notification filed by Becton, Dickinson Company with the FDA for Bd Flowsmart Set.

Pre-market Notification Details

Device IDK150059
510k NumberK150059
Device Name:BD FlowSmart Set
ClassificationSet, Administration, Intravascular
Applicant BECTON, DICKINSON COMPANY 1 BECTON DRIVE Franklin Lakes,  NJ  07666
ContactAvital Merl
CorrespondentAvital Merl
BECTON, DICKINSON COMPANY 1 BECTON DRIVE Franklin Lakes,  NJ  07666
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-13
Decision Date2015-04-28
Summary:summary

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