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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 K052480
Device Name HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
Applicant
HANSEN MEDICAL, INC.
380 NORTH BERNARDO AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact NINA PELED
Correspondent
HANSEN MEDICAL, INC.
380 NORTH BERNARDO AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact NINA PELED
Regulation Number870.1290
Classification Product Code
DXX  
Subsequent Product Code
DRA  
Date Received09/09/2005
Decision Date 05/02/2007
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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