VOYAGER NC CORONARY DILATATION CATHETER

  • Modelo / Serial
    Model Catalog: 1011759-12 (Lot serial: 8062361); Model Catalog: 1011759-08 (Lot serial: 8062361); Model Catalog: 1011759-12 (Lot serial: 8041051); Model Catalog: 1011759-08 (Lot serial: 8041051); Model Catalog: 1011759-12 (Lot serial: 8050561); Model Catalog: 1011759-08 (Lot serial: 8050561); Model Catalog: 1011759-12 (Lot serial: 8050961); Model Catalog: 1011759-08 (Lot serial: 8050961)
  • Descripción del producto
    VOYAGER RX CORONARY DILATATION CATHETER
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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
    HC

2 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Part Number: 1011759-08, Lot Numbers: 8050961 and 8062361.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. || The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
  • Manufacturer
  • Modelo / Serial
    Part Number: 1011759-12, Lot Numbers: 8041051, 8050561, 8061961 and Part Number: 1011750-12, Lot Number 8100761.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. || The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
  • Manufacturer