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510(k) K014223

MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM by Medtronic Percusurge, Inc. — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2002
Date Received
December 26, 2001
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

Other clearances by Medtronic Percusurge, Inc.

  • K013913 — PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (November 15, 2002)

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  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)
  • K060651 — PROXIS SYSTEM, MODEL EPS101 (September 13, 2006)
  • K052523 — PROXIS SYSTEM (September 7, 2006)
  • K062201 — SPIDERX EMBOLIC PROTECTION DEVICE (August 11, 2006)
  • K061332 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) (August 11, 2006)
  • K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM (July 11, 2006)
  • K053195 — SPIDERX EMBOLIC PROTECTION DEVICE (June 23, 2006)