NMI PICC III

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

NAVILYST MEDICAL, INC.

The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Nmi Picc Iii.

Pre-market Notification Details

Device IDK133264
510k NumberK133264
Device Name:NMI PICC III
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough,  MA  01752
ContactBrandon Brackett
CorrespondentBrandon Brackett
NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough,  MA  01752
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-23
Decision Date2013-11-20
Summary:summary

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