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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 K121196
Models H74929189XX150, H74939190XX150, H74929191XX150, H74939192XX150
Device Name EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove,  MN  55311 1566
Original Contact vicky l hagens
Regulation Number870.5100
Classification Product Code
LOX  
Date Received04/19/2012
Decision Date 08/31/2012
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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