IV Sets Not Made With PVC

Set, Administration, Intravascular

B. Braun Medical Inc.

The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Iv Sets Not Made With Pvc.

Pre-market Notification Details

Device IDK191658
510k NumberK191658
Device Name:IV Sets Not Made With PVC
ClassificationSet, Administration, Intravascular
Applicant B. Braun Medical Inc. 901 Marcon Boulevard Allentown,  PA  18109
ContactAngela J. Caravella
CorrespondentAngela J. Caravella
B. Braun Medical Inc. 901 Marcon Boulevard Allentown,  PA  18109
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-21
Decision Date2020-03-19

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