SOFT-CELL DUAL LUMEN 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 Soft-cell Dual Lumen Catheters.

Pre-market Notification Details

Device IDK030277
510k NumberK030277
Device Name:SOFT-CELL DUAL LUMEN CATHETERS
ClassificationCatheter, Hemodialysis, Implanted
Applicant C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
ContactGlenn Norton
CorrespondentGlenn Norton
C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
Product CodeMSD  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-27
Decision Date2003-08-06
Summary:summary

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