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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 K160919
Device Name Hansen Medical Magellan Robotic Catheter 9Fr
Applicant
Hansen Medical, Inc.
800 E Middlefield Rd.
Mountain View,  CA  94043
Applicant Contact MARYSA LOUSTALOT
Correspondent
Hansen Medical, Inc.
800 E Middlefield Rd.
Mountain View,  CA  94043
Correspondent Contact MARYSA LOUSTALOT
Regulation Number870.1280
Classification Product Code
DRA  
Date Received04/04/2016
Decision Date 09/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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