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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 K060175
Device Name ISIGHT IMAGING CATHETER, MODEL 38986
Original Applicant
BOSTON SCIENTIFIC CORP.
47900 bayside parkway
fremont,  CA  94538
Original Contact robert z phillips
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/23/2006
Decision Date 03/24/2006
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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