Q-PORT SYSTEM KIT

Port & Catheter, Implanted, Subcutaneous, Intravascular

QUINTON, INC.

The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Q-port System Kit.

Pre-market Notification Details

Device IDK894650
510k NumberK894650
Device Name:Q-PORT SYSTEM KIT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
ContactRon Duck
CorrespondentRon Duck
QUINTON, INC. 2121 TERRY AVE. Seatle,  WA  98121
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-24
Decision Date1990-03-12

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