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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 K173762
Device Name AngioDynamics, Inc. Soft-Vu and Mariner Angiographic 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 Received12/11/2017
Decision Date 07/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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