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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, diagnostic
510(k) Number K063312
Device Name MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
Original Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont,  CA  94538 6515
Original Contact robert z phillips
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
ITX  
Date Received11/02/2006
Decision Date 11/30/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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