Pristine Long-Term Hemodialysis Catheter

Catheter, Hemodialysis, Implanted

C B Bard, Inc

The following data is part of a premarket notification filed by C B Bard, Inc with the FDA for Pristine Long-term Hemodialysis Catheter.

Pre-market Notification Details

Device IDK203767
510k NumberK203767
Device Name:Pristine Long-Term Hemodialysis Catheter
ClassificationCatheter, Hemodialysis, Implanted
Applicant C B Bard, Inc 1625 W Third Street Tempe,  AZ  85281
ContactArieona Boyle
CorrespondentArieona Boyle
C B Bard, Inc 1625 W Third Street Tempe,  AZ  85281
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-23
Decision Date2021-04-02

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