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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheters, transluminal coronary angioplasty, percutaneous
510(k) Number K163174
Device Name Emerge PTCA Dilatation Catheter
Applicant
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55311
Applicant Contact Jane Horan
Correspondent
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Jane Horan
Regulation Number870.5100
Classification Product Code
LOX  
Date Received11/14/2016
Decision Date 12/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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