COBRA Fusion Ablation System

  • Model / 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    AtriCure, Inc., 7555 Innovation Way, Mason OH 45040-9695
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

4 devices with a similar name

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  • Model / Serial
  • Product Description
    aimd
  • Manufacturer
    XXX
  • Model / Serial
  • Product Description
    Medical electronics / Electromedical devices - electrotherapy
  • Manufacturer
  • Model / Serial
    Model Number: 001-700-001S 001-700-001MI 001-700-002 001-700-003
  • Product Description
    Electromechanical medical devices
  • Manufacturer
  • Model / Serial
  • Product Description
    AtriCure: Cobra Fusion Ablation System
  • Manufacturer