Devices

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

  • Modèle / numéro de série
    Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to the state of : Illinois
  • Description du dispositif
    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
    CryoLife, Inc.
  • 1 Event

Fabricant

CryoLife, Inc.
  • Adresse du fabricant
    CryoLife, Inc., 1655 Roberts Blvd NW, Kennesaw GA 30144-3632
  • Société-mère du fabricant (2017)
    Cryolife Inc.
  • Source
    USFDA