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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K112697
Device Name CHARGER PTA BALLON DILATATION CATHETER
Applicant
Boston Scientific
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact GLENN JACQUES
Correspondent
Boston Scientific
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact GLENN JACQUES
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received09/16/2011
Decision Date 11/30/2011
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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