Devices

Device Recall CryoValve Allograft

  • 모델명 / 제조번호(시리얼번호)
    Donor #61266, Serial # 7701969, Model #AV00; Donor #63307, Serial #7899279, Model # SGAV00; Donor #64489, Serial #7869356, Model # SGPV00; Donor #65674, Serial # 7957300 Model #SGPV00; Donor #64879, Serial # 7883273, Model #SGPV00; Donor #64697, Serial #7876274, Model #PV00.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts.
  • 제품 설명
    CryoValve Allograft, heart valve
  • Manufacturer
    Cryolife Inc
  • 1 Event

제조사

Cryolife Inc
  • 제조사 주소
    Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall CryoValve Allograft heart valve
  • 모델명 / 제조번호(시리얼번호)
    Model number SGPV00, Serial Number: 7291867, Donor #55899
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.
  • 제품 설명
    CryoValve Allograft heart valve
  • Manufacturer
    Cryolife Inc
Device Recall CryoValve Allograft heart valve
  • 모델명 / 제조번호(시리얼번호)
    Model number PV00, Serial Number: 7255205, Donor #56190
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    One unit was distributed to one Hospital facility in NY. There are no foreign or government accounts involved.
  • 제품 설명
    CryoValve Allograft heart valve
  • Manufacturer
    Cryolife Inc
Device Recall CryoValve Allograft
  • 모델명 / 제조번호(시리얼번호)
    Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.
  • 제품 설명
    CryoValve Allograft, Heart valve
  • Manufacturer
    Cryolife Inc