BD FlowSmart Set/MiniMed Pro-Set

Set, Administration, Intravascular

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Flowsmart Set/minimed Pro-set.

Pre-market Notification Details

Device IDK181718
510k NumberK181718
Device Name:BD FlowSmart Set/MiniMed Pro-Set
ClassificationSet, Administration, Intravascular
Applicant Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
ContactMeriam Youssef
CorrespondentMeriam Youssef
Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-29
Decision Date2018-10-18
Summary:summary

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