Device Recall Elana Surgical KitHUD

  • 모델명 / 제조번호(시리얼번호)
    Manufacturers Product Number, 801-H  Lot/Serial Number, 160301
  • 의료기기 분류등급
  • 의료기기 등급
    HDE
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
  • 제품 설명
    Elana Surgical KitHUD || The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Elana, Inc., 10480 Little Patuxent Pkwy Ste 400, Columbia MD 21044-3576
  • Source
    USFDA