Device Recall Diamondback 360, CSI ViperWire

  • Modèle / numéro de série
    Lot: P1406641
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Cardiovascular Systems, Inc., 651 Campus Dr, Arden Hills MN 55112-3495
  • Société-mère du fabricant (2017)
  • Source
    USFDA