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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 K143193
Device Name Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
Applicant
BOSTON SCIENTIFIC
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact Anna Deraney
Correspondent
BOSTON SCIENTIFIC
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact Anna Deraney
Regulation Number870.1250
Classification Product Code
LIT  
Date Received11/06/2014
Decision Date 07/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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