AngioVac C20, AngioVac C180

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

AngioDynamics, Inc.

The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiovac C20, Angiovac C180.

Pre-market Notification Details

Device IDK190594
510k NumberK190594
Device Name:AngioVac C20, AngioVac C180
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant AngioDynamics, Inc. 26 Forest St. Marlborough,  MA  01752
ContactKasey Newcomb
CorrespondentKasey Newcomb
AngioDynamics, Inc. 26 Forest St. Marlborough,  MA  01752
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-07
Decision Date2019-07-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H965251940 K190594 000
H965251930 K190594 000
15051684016506 K190594 000

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