Device Recall Diamondback 360, CSI ViperWire

  • Modelo / Serial
    Lot: P1406641
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cardiovascular Systems, Inc., 651 Campus Dr, Arden Hills MN 55112-3495
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA