Device Recall AFX Endovascular AAA System, Endoleak Type IIIB

  • 모델명 / 제조번호(시리얼번호)
    The correction is not lot specific. It applies to AFX procedures conducted after July 2015
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • 제품 설명
    AFX Endovascular AAA System, Endoleak Type IIIB; || The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Endologix, 35 Hammond, Irvine CA 92618-1607
  • 제조사 모회사 (2017)
  • Source
    USFDA