BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

BOSTONSCIENTIFIC

The following data is part of a premarket notification filed by Bostonscientific with the FDA for Boston Scientific Peripherally Inserted Central Catheter.

Pre-market Notification Details

Device IDK070002
510k NumberK070002
Device Name:BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant BOSTONSCIENTIFIC 100 BOSTON SCIENTIFIC WAY Marlborough,  MA  01752
ContactNicholas Condakes
CorrespondentNicholas Condakes
BOSTONSCIENTIFIC 100 BOSTON SCIENTIFIC WAY Marlborough,  MA  01752
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-03
Decision Date2007-08-17
Summary:summary

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