Hansen Medical Inc

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Description

3 dispositivos en la base de datos

  • Modelo / Serial
    Lot number 20151117
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to OH, TX. FL, CA and GA.
  • Descripción del producto
    Magellan Robotic Catheter Accessory Kits, || Model number MACC 50 and MACC80. || Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
  • Modelo / Serial
    All serial numbers.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
  • Descripción del producto
    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
  • Modelo / Serial
    Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.
  • Descripción del producto
    Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. || Product Usage: || The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.

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Más información acerca de la data acá

  • Dirección del fabricante
    Hansen Medical Inc, 380 N. Bernardo Ave., Mountain View CA 94043-5207
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA