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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Thrombolysis Catheter
510(k) Number K151554
Device Name Occlusion Perfusion Catheter
Applicant
Advanced Catheter Therapies, Inc.
25 E. Main St., Suite 205
Chattanooga,  TN  37408
Applicant Contact PAUL JOSEPH FITZPATRIC
Correspondent
Regulatory Compliance Associates, Inc.
10411 Corporate Dr.
Suite 102
Pleasant Prarie,  WI  53158
Correspondent Contact CHRIS HENZA
Regulation Number870.5150
Classification Product Code
QEY  
Date Received06/09/2015
Decision Date 09/15/2015
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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