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510(k) K052523

PROXIS SYSTEM by Velocimed, Inc. — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2006
Date Received
September 14, 2005
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 Velocimed, Inc.

  • K043084 — PREMERE DELIVERY SHEATH, MODEL PDS (May 2, 2005)
  • K042117 — PROXIS SYSTEM, MODEL EPS 101 (January 7, 2005)
  • K042910 — VENTURE WIRE CONTROL CATHETER, MODEL WCC (November 22, 2004)
  • K040922 — VENTURE WIRE CONTROL CATHETER (August 18, 2004)
  • K023548 — PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 (August 4, 2003)

Other clearances for product code NFA

  • K073523 — INTERCEPTOR PLUS CORONARY FILTER SYSTEMS (August 1, 2008)
  • K073563 — MODIFICATION TO PROXIS SYSTEM (January 31, 2008)
  • K063785 — SPIDERFX EMBOLIC PROTECTION DEVICE (January 19, 2007)
  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)
  • K060651 — PROXIS SYSTEM, MODEL EPS101 (September 13, 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)
  • K051984 — FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20 (April 10, 2006)