Devices

Device Recall Outback Percutaneous catheter

  • Modelo / Serial
    Model number OTB 1235, Dates of manufacture 11-2003, 03-2004 and 04-2004. Model number OTB 1245, Dates of manufacture 11-2003. 510(k) K032298.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Sent mainly to Area sales representatives.
  • Descripción del producto
    LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
  • Manufacturer
    Lumend Inc
  • 1 Event

Fabricante

Lumend Inc
  • Dirección del fabricante
    Lumend Inc, 400 Chesapeake Dr, Redwood City CA 94063-4739
  • Source
    USFDA