PLASTIC LOW PROFILE SUBCUTANEOUS PORT

Port & Catheter, Implanted, Subcutaneous, Intravascular

BARD ACCESS SYSTEMS, INC.

The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Plastic Low Profile Subcutaneous Port.

Pre-market Notification Details

Device IDK924250
510k NumberK924250
Device Name:PLASTIC LOW PROFILE SUBCUTANEOUS PORT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City,  UT  84116
ContactJack Speer
CorrespondentJack Speer
BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City,  UT  84116
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-24
Decision Date1993-10-04

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