Zenysis Short-Term Dialysis Catheter

Catheter, Hemodialysis, Non-implanted

C.R BARD INC.

The following data is part of a premarket notification filed by C.r Bard Inc. with the FDA for Zenysis Short-term Dialysis Catheter.

Pre-market Notification Details

Device IDK153190
510k NumberK153190
Device Name:Zenysis Short-Term Dialysis Catheter
ClassificationCatheter, Hemodialysis, Non-implanted
Applicant C.R BARD INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
ContactSilvia De La Barra
CorrespondentSilvia De La Barra
C.R BARD INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
Product CodeMPB  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-03
Decision Date2016-01-05
Summary:summary

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