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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 K130391
Device Name EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
Applicant
Boston Scientific Corp
Two Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact VICKY L HAGENS
Correspondent
Boston Scientific Corp
Two Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact VICKY L HAGENS
Regulation Number870.5100
Classification Product Code
LOX  
Date Received02/15/2013
Decision Date 07/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01635881
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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