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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name temporary coronary saphenous vein bypass graft for embolic protection
510(k) Number K052280
Device Name FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW,  CA  94043 -4655
Applicant Contact DEBBIE MCINTIRE
Correspondent
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW,  CA  94043 -4655
Correspondent Contact DEBBIE MCINTIRE
Regulation Number870.1250
Classification Product Code
NFA  
Date Received08/22/2005
Decision Date 11/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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