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 IDK160651
510k NumberK160651
Device Name:BD FlowSmart Set, MiniMed Pro-Set
ClassificationSet, Administration, Intravascular
Applicant BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes,  NJ  07666
ContactMatthew Trachtenberg
CorrespondentMatthew Trachtenberg
BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes,  NJ  07666
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-08
Decision Date2016-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903286176 K160651 000
50382903286169 K160651 000
50382903286152 K160651 000
50382903286145 K160651 000
50382903286138 K160651 000
00382903286126 K160651 000
50382903286114 K160651 000
50382903286107 K160651 000

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