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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name temporary carotid catheter for embolic capture
510(k) Number K063313
Device Name FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
Applicant
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW,  CA  94043
Applicant Contact DONNA PAGE
Correspondent
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact DONNA PAGE
Regulation Number870.1250
Classification Product Code
NTE  
Date Received11/02/2006
Decision Date 12/05/2006
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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