CELSITE/ CELSITE CONCEPT, ACCESS PORTS

Port & Catheter, Implanted, Subcutaneous, Intravascular

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Celsite/ Celsite Concept, Access Ports.

Pre-market Notification Details

Device IDK061424
510k NumberK061424
Device Name:CELSITE/ CELSITE CONCEPT, ACCESS PORTS
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactLisa Boyle
CorrespondentLisa Boyle
AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-23
Decision Date2006-07-31
Summary:summary

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