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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 K141822
Device Name SENSEI X ROBOTIC CATHETER SYSTEM
Applicant
HANSON MEDICAL, INC.
800 EAST MIDDLEFIELD RD
MOUNTAIN VIEW,  CA  94043
Applicant Contact TODD MILHOLLAND
Correspondent
HANSON MEDICAL, INC.
800 EAST MIDDLEFIELD RD
MOUNTAIN VIEW,  CA  94043
Correspondent Contact TODD MILHOLLAND
Regulation Number870.1290
Classification Product Code
DXX  
Date Received07/07/2014
Decision Date 08/05/2014
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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