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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 K153304
Device Name Hansen Medical Magellan Robotic Catheter eKit
Applicant
Hansen Medical, Inc.
800 E Middlefield Road
Mountain View,  CA  94043
Applicant Contact Marysa Loustalot
Correspondent
Hansen Medical, Inc.
800 E Middlefield Road
Mountain View,  CA  94043
Correspondent Contact Marysa Loustalot
Regulation Number870.1280
Classification Product Code
DRA  
Date Received11/16/2015
Decision Date 02/01/2016
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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