PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER

Port & Catheter, Implanted, Subcutaneous, Intravascular

SIMS DELTEC, INC.

The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Proport Plastic Venous Implantable Access Systems Pre-assembled With Silicone Catheter.

Pre-market Notification Details

Device IDK010426
510k NumberK010426
Device Name:PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul,  MN  55112
ContactLisa J Stone
CorrespondentLisa J Stone
SIMS 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 Received2001-02-13
Decision Date2001-03-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00610586012627 K010426 000
10610586012860 K010426 000
10610586012846 K010426 000
10610586012600 K010426 000

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