Device Recall Zilver 518 Vascular Self Expanding Stent

  • Modèle / numéro de série
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • Description du dispositif
    Zilver 518 Vascular Self Expanding Stent || The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cook Ireland Ltd., O'holloran Road,, National Technological Park, Limerick, Peroc Ireland
  • Société-mère du fabricant (2017)
  • Source
    USFDA