GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters

Catheter, Hemodialysis, Implanted

C.R. Bard

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

Pre-market Notification Details

Device IDK190527
510k NumberK190527
Device Name:GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
ClassificationCatheter, Hemodialysis, Implanted
Applicant C.R. Bard 605 N 5600 W Salt Lake City,  UT  84116
ContactJonathan Holmes
CorrespondentJoan Bergstrom
Bard Access Systems, Inc. 1625 West 3rd Street Tempe,  UT  85281
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-04
Decision Date2020-03-05

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