PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set

Set, Administration, Intravascular

C.R BARD, INC.

The following data is part of a premarket notification filed by C.r Bard, Inc. with the FDA for Powerloc Max Power Injectable Infusion Set, Safestep Huber Needle Set.

Pre-market Notification Details

Device IDK153440
510k NumberK153440
Device Name:PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
ClassificationSet, Administration, Intravascular
Applicant C.R BARD, INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
ContactDarlene Hull
CorrespondentDarlene Hull
C.R BARD, INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-27
Decision Date2016-08-18
Summary:summary

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