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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Cutting/Scoring
510(k) Number K122685
Device Name ANGIOSCULPT PTA SCORING BALLOON CATHETER
Applicant
Angioscore, Inc.
5055 Brandin Court
Fremont,  CA  94538
Applicant Contact KIMBERLEY KLINE
Correspondent
Angioscore, Inc.
5055 Brandin Court
Fremont,  CA  94538
Correspondent Contact KIMBERLEY KLINE
Regulation Number870.1250
Classification Product Code
PNO  
Date Received08/31/2012
Decision Date 01/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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