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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 COURT
FREMONT,  CA  94538
Applicant Contact KARIN J GASTINEAU
Correspondent
ANGIOSCORE, INC.
5055 BRANDIN COURT
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
Recalls CDRH Recalls
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