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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
Device Name RUBICON 18 SUPPORT CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311 -1566
Applicant Contact diane nelson
Correspondent
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311 -1566
Correspondent Contact diane nelson
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/07/2012
Decision Date 08/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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