Device Recall iCAST and Advanta

  • 모델명 / 제조번호(시리얼번호)
    Part Number 85455: Lots 240735, 240523;  Part Number 85355: Lot 240734
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
  • 제품 설명
    Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) || Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) || The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • 제조사 모회사 (2017)
  • Source
    USFDA