Device Recall TorFlex Transseptal Guiding Sheath

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: S21244, S21903, S21940, S22739 and S22739X1.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Canada, Chile, China, Colombia, Denmark, Egypt, France, Germany, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Portugal, Qatar, Russia, Singapore, South Africa, Sweden, Switzerland, United Arab Emirates and the United Kingdom.
  • 제품 설명
    Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. || Intended to allow left heart catheterization procedure to occur through the right atrium.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Baylis Medical Corp *, 5959 Trans-Canada Hwy, Montreal Canada
  • Source
    USFDA