TRIMPORT

Port & Catheter, Implanted, Subcutaneous, Intravascular

GERARD MEDICAL ENTERPRISES, INC.

The following data is part of a premarket notification filed by Gerard Medical Enterprises, Inc. with the FDA for Trimport.

Pre-market Notification Details

Device IDK945250
510k NumberK945250
Device Name:TRIMPORT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant GERARD MEDICAL ENTERPRISES, INC. 90 WORCESTER RD. Charlton,  MA  01507
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-28
Decision Date1995-03-07

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