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510(k) K062201

SPIDERX EMBOLIC PROTECTION DEVICE by Ev3, Inc. — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2006
Date Received
August 1, 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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  • 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)
  • 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)
  • K051984 — FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20 (April 10, 2006)