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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 K141521
Device Name MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact MELANIE RASKA
Correspondent
Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact MELANIE RASKA
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/09/2014
Decision Date 08/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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