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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
Model MODEL 1012
Device Name AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
Original Applicant
CATHETER ROBOTICS INC
500 international drive
mount olive,  NJ  07828
Original Contact jennifer englund
Regulation Number870.1290
Classification Product Code
DXX  
Date Received12/08/2011
Decision Date 06/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT01139814
Reviewed by Third Party No
Expedited Review No
Combination Product No
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