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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 K150634
Device Name AngioSculpt PTA Scoring Baloon Catheters
Applicant
Spectranetrics
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact Kimberley Kline
Correspondent
Spectranetics
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact Kimberley Kline
Regulation Number870.1250
Classification Product Code
PNO  
Date Received03/11/2015
Decision Date 04/08/2015
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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