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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 K050629
Device Name ANGIOSCULPT SCORING BALLOON CATHETER
Applicant
Angioscore, Inc.
965 Atlantic Ave., Suite 101,
Alameda,  CA  94501
Applicant Contact GARY GERSHONY
Correspondent
Angioscore, Inc.
965 Atlantic Ave., Suite 101,
Alameda,  CA  94501
Correspondent Contact GARY GERSHONY
Regulation Number870.1250
Classification Product Code
PNO  
Date Received03/11/2005
Decision Date 09/02/2005
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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