VAXCEL WITH PASV PORT, MODEL 45-213

Port & Catheter, Implanted, Subcutaneous, Intravascular

BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Vaxcel With Pasv Port, Model 45-213.

Pre-market Notification Details

Device IDK032008
510k NumberK032008
Device Name:VAXCEL WITH PASV PORT, MODEL 45-213
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick,  MA  01760
ContactJodi Lynn Greenizen
CorrespondentJodi Lynn Greenizen
BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick,  MA  01760
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-30
Decision Date2003-07-14
Summary:summary

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