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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
510(k) Number K060572
Device Name MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
Applicant
Boston Scientific Corporation
160 Knowles Dr.
Lost Gatos,  CA  95032
Applicant Contact ELAINE APLAON
Correspondent
Boston Scientific Corporation
160 Knowles Dr.
Lost Gatos,  CA  95032
Correspondent Contact ELAINE APLAON
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received03/06/2006
Decision Date 03/15/2006
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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