GlidePath 13F Long-Term Hemodialysis Catheter

Catheter, Hemodialysis, Implanted

Bard Peripheral Vascular, Inc

The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc with the FDA for Glidepath 13f Long-term Hemodialysis Catheter.

Pre-market Notification Details

Device IDK211410
510k NumberK211410
Device Name:GlidePath 13F Long-Term Hemodialysis Catheter
ClassificationCatheter, Hemodialysis, Implanted
Applicant Bard Peripheral Vascular, Inc 1625 West 3rd Street Tempe,  AZ  85281
ContactJoan Bergstrom
CorrespondentJoan Bergstrom
Bard Peripheral Vascular, Inc 1625 West 3rd Street Tempe,  AZ  85281
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-06
Decision Date2021-06-04

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