POWERPORT CLEARVUE SLIM IMPLANTABLE PORT

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 Powerport Clearvue Slim Implantable Port.

Pre-market Notification Details

Device IDK122899
510k NumberK122899
Device Name:POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
ContactAmy Honey
CorrespondentAmy Honey
C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City,  UT  84116
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-21
Decision Date2012-11-15
Summary:summary

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