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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 K113220
Device Name EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
Applicant
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact VICKY L HAGENS
Correspondent
Boston Scientific Corporation
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact VICKY L HAGENS
Regulation Number870.5100
Classification Product Code
LOX  
Date Received11/01/2011
Decision Date 03/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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