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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K190594
Device Name AngioVac C20, AngioVac C180
Applicant
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact Kasey Newcomb
Correspondent
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact Kasey Newcomb
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/07/2019
Decision Date 07/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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