Device Recall Zilver 518 Vascular Self Expanding Stent

  • 모델명 / 제조번호(시리얼번호)
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Cook Ireland Ltd., O'holloran Road,, National Technological Park, Limerick, Peroc Ireland
  • 제조사 모회사 (2017)
  • Source
    USFDA