PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM

Port & Catheter, Implanted, Subcutaneous, Intravascular

PHARMACIA DELTEC, INC.

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

Pre-market Notification Details

Device IDK875276
510k NumberK875276
Device Name:PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
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 CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-24
Decision Date1988-04-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.