Xcela PICC With PASV, Xcela Hybrid PICC With PASV, Xcela Power Injectable PICC

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 Xcela Picc With Pasv, Xcela Hybrid Picc With Pasv, Xcela Power Injectable Picc.

Pre-market Notification Details

Device IDK152409
510k NumberK152409
Device Name:Xcela PICC With PASV, Xcela Hybrid PICC With PASV, Xcela Power Injectable PICC
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough,  MA  01752
ContactRobin Fuller
CorrespondentRobin Fuller
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 Received2015-08-26
Decision Date2015-09-24
Summary:summary

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