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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 K121196
Device Name EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
Applicant
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact VICKY L HAGENS
Correspondent
BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact VICKY L HAGENS
Regulation Number870.5100
Classification Product Code
LOX  
Date Received04/19/2012
Decision Date 08/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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