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FDA 510(k) Application Details - K052480
Device Classification Name
System, Catheter Control, Steerable
More FDA Info for this Device
510(K) Number
K052480
Device Name
System, Catheter Control, Steerable
Applicant
HANSEN MEDICAL, INC.
380 NORTH BERNARDO AVE.
MOUNTAIN VIEW, CA 94043 US
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Contact
NINA PELED
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Regulation Number
870.1290
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Classification Product Code
DXX
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More FDA Info for this Product Code
Date Received
09/09/2005
Decision Date
05/02/2007
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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