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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 K141236
Device Name NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
Applicant
Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact ADRIENNE HOTCHKISS
Correspondent
Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact ADRIENNE HOTCHKISS
Regulation Number870.5100
Classification Product Code
LOX  
Date Received05/13/2014
Decision Date 08/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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