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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
Device Name ARTISAN EXTEND CONTROL CATHETER
Applicant
Hansen Medical
800 EAST MIDDLEFIELD ROAD
MOUNTAIN VIEW,  CA  94043
Applicant Contact HASSAN LABAY
Correspondent
Hansen Medical
800 EAST MIDDLEFIELD ROAD
MOUNTAIN VIEW,  CA  94043
Correspondent Contact HASSAN LABAY
Regulation Number870.1280
Classification Product Code
DRA  
Date Received07/30/2012
Decision Date 08/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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