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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 K011664
Device Name IMAGER II ANGIOGRAPHIC CATHETER
Original Applicant
BOSTON SCIENTIFIC/MEDI-TECH
one boston scientific place
natick,  MA  01760 1537
Original Contact jodi l greenizen
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/30/2001
Decision Date 09/07/2001
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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