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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 K023681
Device Name RENEGADE STC 18 MICROCATHETER
Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick,  MA  01760
Contact christine m cameron
Regulation Number870.1200
Classification Product Code
DQO  
Date Received11/01/2002
Decision Date 11/26/2002
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
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