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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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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