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510(k) K023878

GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM by Medtronic Vascular — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2003
Date Received
November 21, 2002
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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