Device Recall CryoValve

Fabricante

  • Dirección del fabricante
    Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144-3632
  • Source
    USFDA

29 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    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.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts.
  • Descripción del producto
    CryoValve Allograft, heart valve
  • Manufacturer
  • Modelo / Serial
    Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.
  • Descripción del producto
    CryoValve Allograft, Heart valve
  • Manufacturer
  • Modelo / Serial
    Aortic Valve & Conduit, Donor #29976, Serial #6212891, Model #AV00 and Pulmonary Valve & Conduit Donor #51562, Serial #7093095, Model #PV00
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Heart allografts were distributed to two hospitals in OH and Quebec, Canada.
  • Descripción del producto
    CryoValve Allograft, Heart valve.
  • Manufacturer
  • Modelo / Serial
    Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695, Serial #6356214, Model #PV00.
  • Distribución
    Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted.
  • Descripción del producto
    CryoValve Heart-valve, allograft
  • Manufacturer
  • Modelo / Serial
    Model #PV00, Serial #7916346
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Allograft was distributed to and implanted by one physician in California.
  • Descripción del producto
    CryoValve Allograft, Pulmonary Heart valve & Conduit.
  • Manufacturer
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