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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 K022621
Device Name BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
Original Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick,  MA  01760
Original Contact heidi m erickson
Regulation Number870.1200
Classification Product Code
DQO  
Date Received08/07/2002
Decision Date 09/04/2002
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
Recalls CDRH Recalls
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