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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 K073225
Device Name SENSEI CATHETER CONTROL SYSTEM
Applicant
HANSEN MEDICAL, INC.
380 NORTH BERNARDO AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact DOUG WORTH
Correspondent
HANSEN MEDICAL, INC.
380 NORTH BERNARDO AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact DOUG WORTH
Regulation Number870.1290
Classification Product Code
DXX  
Subsequent Product Code
DRA  
Date Received11/15/2007
Decision Date 06/30/2008
Decision SE - With Limitations (SESU)
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
Recalls CDRH Recalls
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