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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 K050684
Device Name ATLANTIS PV
Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont,  CA  94538 6515
Contact robert z phillips
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Code
ITX  
Date Received03/17/2005
Decision Date 05/20/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Radiology
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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