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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 K142983
Device Name AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
Applicant
Angioscore, Inc.
5055 Brandin Ct.
Fremont,  CA  94538
Applicant Contact Kimberley Kline
Correspondent
Angioscore, Inc.
5055 Brandin Ct.
Fremont,  CA  94538
Correspondent Contact Kimberley Kline
Regulation Number870.1250
Classification Product Code
PNO  
Date Received10/16/2014
Decision Date 03/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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