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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, steerable
510(k) Number K122275
Model 12412
Device Name ARTISAN EXTEND CONTROL CATHETER
Original Applicant
HANSEN MEDICAL
800 east middlefield road
mountain view,  CA  94043
Original Contact hassan labay
Regulation Number870.1280
Classification Product Code
DRA  
Date Received07/30/2012
Decision Date 08/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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