HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS

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 Hemoglide Series And Hemoglide Star Series Xk Long-term Hemodialysis Catheters.

Pre-market Notification Details

Device IDK051748
510k NumberK051748
Device Name:HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
ClassificationCatheter, Hemodialysis, Implanted
Applicant C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
ContactMichaela Rivkowich
CorrespondentMichaela Rivkowich
C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-29
Decision Date2005-08-12
Summary:summary

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