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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K070126
Device Name OCCLUSION BALLOON CATHETER
Original Applicant
SENTREHEART INC.
2468 embarcadero way
palo alto,  CA  94303
Original Contact linda guthrie
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/16/2007
Decision Date 02/08/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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