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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 K080151
Device Name ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
Applicant
Angioscore, Inc.
5055 Brandin Ct.
Fremont,  CA  94538
Applicant Contact KARIN J GASTINEAU
Correspondent
Angioscore, Inc.
5055 Brandin Ct.
Fremont,  CA  94538
Correspondent Contact KARIN J GASTINEAU
Regulation Number870.1250
Classification Product Code
PNO  
Date Received01/22/2008
Decision Date 04/25/2008
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
Recalls CDRH Recalls
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