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510(k) K062870

TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 by Kensey Nash Corp. — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2006
Date Received
September 25, 2006
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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