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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K161596
Device Name Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
Applicant
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Applicant Contact Teri Juckett
Correspondent
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Correspondent Contact Teri Juckett
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/09/2016
Decision Date 04/28/2017
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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