PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM

Port & Catheter, Implanted, Subcutaneous, Intraperitoneal

PHARMACIA DELTEC, INC.

The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Port-a-cath Implantable Drug Delivery System.

Pre-market Notification Details

Device IDK880072
510k NumberK880072
Device Name:PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
ClassificationPort & Catheter, Implanted, Subcutaneous, Intraperitoneal
Applicant PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactEdward Numainville
CorrespondentEdward Numainville
PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
Product CodeLLD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-11
Decision Date1988-03-29

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