TRIUMPH-1 PORT

Port & Catheter, Implanted, Subcutaneous, Intravascular

HORIZON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Horizon Medical Products, Inc. with the FDA for Triumph-1 Port.

Pre-market Notification Details

Device IDK951814
510k NumberK951814
Device Name:TRIUMPH-1 PORT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant HORIZON MEDICAL PRODUCTS, INC. 4200 NORTHSIDE PARKWAY N.W. Atlanta,  GA  30327
ContactRoddy J. H Clark
CorrespondentRoddy J. H Clark
HORIZON MEDICAL PRODUCTS, INC. 4200 NORTHSIDE PARKWAY N.W. Atlanta,  GA  30327
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-18
Decision Date1995-08-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H787SSDX16I0 K951814 000
H787SSDX14I0 K951814 000
H787SSDX10I0 K951814 000

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