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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 K091808
Device Name SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
Applicant
Hansen Medical, Inc.
800 E Middlefield Rd.
Mountain View,  CA  94043
Applicant Contact KATE WHITIN
Correspondent
Hansen Medical, Inc.
800 E Middlefield Rd.
Mountain View,  CA  94043
Correspondent Contact KATE WHITIN
Regulation Number870.1290
Classification Product Code
DXX  
Date Received06/18/2009
Decision Date 09/10/2009
Decision SE - With Limitations (SESU)
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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