Visualase Visualization Stylets

  • Modèle / numéro de série
    Lot number 151481
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.
  • Description du dispositif
    Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. || The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA