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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 K122394
Model H74939239018, H74939240035
Device Name RUBICON 18 SUPPORT CATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311 1566
Original Contact diane nelson
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/07/2012
Decision Date 08/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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