GlidePath Retro Long-Term Hemodialysis Catheter

Catheter, Hemodialysis, Implanted

C.R. Bard, Inc.

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

Pre-market Notification Details

Device IDK203575
510k NumberK203575
Device Name:GlidePath Retro Long-Term Hemodialysis Catheter
ClassificationCatheter, Hemodialysis, Implanted
Applicant C.R. Bard, Inc. 1625 W. Third Street Tempe,  AZ  85281
ContactJoan Bergstrom
CorrespondentJoan Bergstrom
C.R. 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 Received2020-12-07
Decision Date2021-07-01

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.