PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS

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 Dual Lumen Implantable Venous Access.

Pre-market Notification Details

Device IDK932841
510k NumberK932841
Device Name:PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS
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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10610586023644 K932841 000
10610586023637 K932841 000

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