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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name catheter remote control system
De Novo Number DEN140009
Device Name AMIGO REMOTE CATHETER SYSTEM
Requester
catheter robotics, inc.
500 international dr., suite 255
mt. olive,  NJ  07828
Contact jennifer englund
Regulation Number870.5700
Classification Product Code
PJB  
Date Received02/18/2014
Decision Date 12/18/2014
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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