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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheters, transluminal coronary angioplasty, percutaneous
510(k) Number K121667
Model H74939124
Device Name NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311 1566
Original Contact laura j lind
Regulation Number870.5100
Classification Product Code
LOX  
Date Received06/06/2012
Decision Date 08/13/2012
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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