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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K971314
Device Name DCAT EMBOLECTOMY CATHETER SYSTEM
Applicant
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Applicant Contact BRIAN KUNST
Correspondent
AngioDynamics, Inc.
603 Queensbury Ave.
Queensburgy,  NY  12804
Correspondent Contact BRIAN KUNST
Regulation Number870.5150
Classification Product Code
DXE  
Date Received04/09/1997
Decision Date 03/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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