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510(k) K023691

BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC by Boston Scientific Epi — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2003
Date Received
November 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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