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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 K151463
Device Name Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
Applicant
Hansen Medical, Inc.
800 E Middlefield Rd.
Mountain View,  CA  94043
Applicant Contact Elisa Aldridge
Correspondent
Hansen Medical, Inc.
800 E Middlefield Rd.
Mountain View,  CA  94043
Correspondent Contact Elisa Aldridge
Regulation Number870.1280
Classification Product Code
DRA  
Date Received06/01/2015
Decision Date 08/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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