CELSITE IMPLANTABLE PORT WITH VALVED CATHETER

Port & Catheter, Implanted, Subcutaneous, Intravascular

B. BRAUN OF AMERICA, INC.

The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Celsite Implantable Port With Valved Catheter.

Pre-market Notification Details

Device IDK993024
510k NumberK993024
Device Name:CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant B. BRAUN OF AMERICA, INC. 901 MARCON BLVD. Allentown,  PA  18103
ContactMark S Alsberge
CorrespondentMark S Alsberge
B. BRAUN OF AMERICA, INC. 901 MARCON BLVD. Allentown,  PA  18103
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-09
Decision Date2000-03-13
Summary:summary

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