XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY

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 Hybrid Picc With Pasv Valve Technology.

Pre-market Notification Details

Device IDK111906
510k NumberK111906
Device Name:XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough,  MA  01752
ContactLorraine M Hanley
CorrespondentLorraine M Hanley
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 Received2011-07-05
Decision Date2011-07-29
Summary:summary

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