FIRMap 60mm Catheter

  • Modèle / numéro de série
    Model number : USAR064060; Lot code: TPR031615-01
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in states of: KY, IN, MO, NY, OH, TX, LA, IL, PA, NJ, WA, VA, FL, GA, CT, CA, AZ, CO, and TN.
  • Description du dispositif
    FIRMap 60mm Catheter; || Size: 60 mm; Length 50.4 inches || French Size Diameter: 8.5F (2.84mm) || Model number : USAR064060 || Sterile, Rx only || Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Electrophysiology, 1530 Obrien Dr, Menlo Park CA 94025-1454
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA