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510(k) K073563

MODIFICATION TO PROXIS SYSTEM by St Jude Medical — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2008
Date Received
December 19, 2007
Clearance Type
Special
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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