Device Recall LeGoo Internal Vessel Occluder 10mL

  • 모델명 / 제조번호(시리얼번호)
    All lot codes
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • 제품 설명
    LeGoo Internal Vessel Occluder 10mL || Product Number: 10-1000 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Genzyme Corporation, A Sanofi Company, 175F New Boston St, Woburn MA 01801-6203
  • 제조사 모회사 (2017)
  • Source
    USFDA