Device Recall CryoValve

  • Model / Serial
    Model #PV00, Serial #7916346
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Allograft was distributed to and implanted by one physician in California.
  • Product Description
    CryoValve Allograft, Pulmonary Heart valve & Conduit.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144
  • Source
    USFDA

29 devices with a similar name

Learn more about the data here

  • Model / Serial
    Donor #69347, Serial #8022177, Model #PV00
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The tissue was distributed to one physician in IN.
  • Product Description
    CryoValve, Pulmonary Valve and Conduit
  • Manufacturer
  • Model / Serial
    Donor #60741, Model #SGAV10, Serial #783013
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.
  • Product Description
    Heart-valve, allograft
  • Manufacturer
  • Model / Serial
    Model number SGPV00, Serial Number: 7291867, Donor #55899
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.
  • Product Description
    CryoValve Allograft heart valve
  • Manufacturer
  • Model / Serial
    Model number PV00, Serial Number: 7255205, Donor #56190
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    One unit was distributed to one Hospital facility in NY. There are no foreign or government accounts involved.
  • Product Description
    CryoValve Allograft heart valve
  • Manufacturer
  • Model / Serial
    Serial Number 10988203
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    AR, OH
  • Product Description
    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
  • Manufacturer
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