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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 K122488
Model 1012
Device Name AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
Applicant
CATHETER ROBOTICS INC
500 international drive
mount olive,  NJ  07828
Contact jennifer englund
Regulation Number870.1290
Classification Product Code
DXX  
Date Received08/15/2012
Decision Date 11/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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