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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Catheter Control, Steerable
510(k) Number K113628
Device Name AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
Applicant
Catheter Robotics, Inc.
500 International Dr.
Mount Olive,  NJ  07828
Applicant Contact JENNIFER ENGLUND
Correspondent
Catheter Robotics, Inc.
500 International Dr.
Mount Olive,  NJ  07828
Correspondent Contact JENNIFER ENGLUND
Regulation Number870.1290
Classification Product Code
DXX  
Date Received12/08/2011
Decision Date 06/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01139814
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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