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510(k) K013913

PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM by Medtronic Percusurge, Inc. — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2002
Date Received
November 27, 2001
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

Other clearances by Medtronic Percusurge, Inc.

  • K014223 — MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM (January 25, 2002)

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