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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, peripheral, atherectomy
510(k) Number K121774
Model M001140*, M00113733*
Device Name ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311 1566
Original Contact beth torok
Regulation Number870.4875
Classification Product Code
MCW  
Date Received06/18/2012
Decision Date 09/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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