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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K122685
Model 2215-20100, 2215-25100, 2215-30100, 2215-35100, 2216-20100, 2216-25100, 2216-30100, 2216-35100
Device Name ANGIOSCULPT PTA SCORING BALLOON CATHETER
Original Applicant
ANGIOSCORE, INC.
5055 brandin court
fremont,  CA  94538
Original Contact kimberley kline
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received08/31/2012
Decision Date 01/11/2013
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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