DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)

Port & Catheter, Implanted, Subcutaneous, Intravascular

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Dual Slim Port Implanted Port (0654970/0654940).

Pre-market Notification Details

Device IDK964066
510k NumberK964066
Device Name:DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant C.R. BARD, INC. BARD ACCESS SYSTEMS 5425 W. AMELIA EARHART DRIVE Salt Lake City,  UT  84116
ContactPeggy Keiffer
CorrespondentPeggy Keiffer
C.R. BARD, INC. BARD ACCESS SYSTEMS 5425 W. AMELIA EARHART DRIVE Salt Lake City,  UT  84116
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-10
Decision Date1997-03-06
Summary:summary

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