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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K130525
Device Name OCCLUSION PERFUSION CATHETER
Applicant
Advanced Catheter Therapies, Inc.
7401 104th Ave.
Kenosha,  WI  53142
Applicant Contact CHRIS HENZA
Correspondent
Advanced Catheter Therapies, Inc.
7401 104th Ave.
Kenosha,  WI  53142
Correspondent Contact CHRIS HENZA
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/28/2013
Decision Date 10/03/2013
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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