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510(k) K070759

POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM by Vidacare Corporation — Product Code FCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2007
Date Received
March 20, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy, Mechanical, Gastrointestinal
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

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  • K113872 — THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE (March 8, 2012)
  • K101026 — POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO (July 27, 2010)
  • K091140 — EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, (October 14, 2009)
  • K081713 — VERTEBRAL ACCESS SYSTEM BY VIDACARE (November 21, 2008)
  • K072045 — ONCONTROL BONE MARROW BIOPSY SYSTEM (October 22, 2007)
  • K063567 — EZ-MIO STERNAL (January 26, 2007)
  • K063142 — MANUAL PD-IO; POWERED PD-IO (December 8, 2006)
  • K062956 — EZ-MIO, EZ-IO DISTAL TIBIA (December 5, 2006)

Other clearances for product code FCF

  • K062833 — POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM (November 30, 2006)
  • K984168 — BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE (December 7, 1999)
  • K915142 — AMCATH DISPOSABLE BIOPSY FORCEPS (January 10, 1992)
  • K911155 — OVAL CUP BIOPSY FORCEP (August 7, 1991)
  • K843477 — PHARMA-PLAST RECTAL TIP (December 5, 1984)