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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 K151730
Device Name Magellan Robotic System
Applicant
Hansen Medical, Inc.
800 E. Middlefield Rd.
Mountain View,  CA  94034
Applicant Contact TODD MILHOLLAND
Correspondent
Hansen Medical, Inc.
800 E. Middlefield Rd.
Mountain View,  CA  94034
Correspondent Contact TODD MILHOLLAND
Regulation Number870.1290
Classification Product Code
DXX  
Date Received06/26/2015
Decision Date 07/23/2015
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
Recalls CDRH Recalls
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