Devices

Device Recall System 98XT/98 IntraAortic Balloon Pump

  • Modèle / numéro de série
    Product number 0998-00-0446-XX and 0998-00-0479-XX. SN# S8119767B8 S8119768B8 S8119769B8 S8119771B8 S8119773B8 S8119774B8 S8119775B8 S8119778B8 S8119780B8 S8119781B8 S8119782B8 S8119764B8 S8119766B8 S8119770B8 S8119772B8 S8119776B8 S8119779B8
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
  • Description du dispositif
    System 98XT/98 Intra-Aortic Balloon Pump || This product was only distributed in India and Hong Kong/China.
  • Manufacturer
    Datascope Corporation
  • 1 Event

Fabricant

Datascope Corporation
  • Adresse du fabricant
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA