PORT-A-CATH IMPLANTABLE VASCULAR ACCESS 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 Implantable Vascular Access System.

Pre-market Notification Details

Device IDK932840
510k NumberK932840
Device Name:PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactDavid Short
CorrespondentDavid Short
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 Received1993-06-11
Decision Date1994-01-05

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