COBRA Fusion Ablation System

  • Modelo / Serial
    Specifically all lots manufactured prior to February 2016. This information can be identified as the symbol for "date of manufacture" on the product label as: MM-YYYY, e.g. 02-2016 or earlier.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, in the following states AL, AR, AZ, CA, CO, CT, GA, FL, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI, & VA; and, to the countries of Albania, Australia, Belgium, France, Germany, Ireland, Italy, Norway, Netherlands, Poland, Sweden, Turkey, United Arab Emirates, & United Kingdom.
  • Descripción del producto
    COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. || Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    AtriCure, Inc., 7555 Innovation Way, Mason OH 45040-9695
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

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  • Descripción del producto
    Medical electronics / Electromedical devices - electrotherapy
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  • Modelo / Serial
    Model Number: 001-700-001S 001-700-001MI 001-700-002 001-700-003
  • Descripción del producto
    Electromechanical medical devices
  • Manufacturer
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  • Descripción del producto
    AtriCure: Cobra Fusion Ablation System
  • Manufacturer