Celerity PICC Tip Confirmation System

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

ANGIODYNAMICS, INC.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Celerity Picc Tip Confirmation System.

Pre-market Notification Details

Device IDK142889
510k NumberK142889
Device Name:Celerity PICC Tip Confirmation System
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough,  MA  01751
ContactMichael Hanley
CorrespondentMichael Hanley
ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough,  MA  01751
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-03
Decision Date2015-01-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H787471470 K142889 000
H787471460 K142889 000
H787471450 K142889 000
H787471440 K142889 000
H787471430 K142889 000
H787471420 K142889 000
H787471400 K142889 000

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