VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P

Port & Catheter, Implanted, Subcutaneous, Intravascular

MED INSTITUTE, INC.

The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Vital-port Vasc Access 901op/911op/9012p/9112p.

Pre-market Notification Details

Device IDK924748
510k NumberK924748
Device Name:VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette,  IN  47906
ContactNeal E Fearnot
CorrespondentNeal E Fearnot
MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette,  IN  47906
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-22
Decision Date1993-07-28

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