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FDA 510(k) Application Details - K073225
Device Classification Name
System, Catheter Control, Steerable
More FDA Info for this Device
510(K) Number
K073225
Device Name
System, Catheter Control, Steerable
Applicant
HANSEN MEDICAL, INC.
380 NORTH BERNARDO AVE.
MOUNTAIN VIEW, CA 94043 US
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Contact
DOUG WORTH
Other 510(k) Applications for this Contact
Regulation Number
870.1290
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Classification Product Code
DXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/15/2007
Decision Date
06/30/2008
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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