Device Recall OnX Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft

  • 모델명 / 제조번호(시리얼번호)
    Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US Distribution to the state of : Illinois
  • 제품 설명
    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. || Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    CryoLife, Inc., 1655 Roberts Blvd NW, Kennesaw GA 30144-3632
  • 제조사 모회사 (2017)
  • Source
    USFDA