Devices

Device Recall 12Fr SLS II Laser Sheath

  • Modelo / Serial
    C11H25B C11H25C C11H25D C11H29E C11H29F C11H29G C11J06A C11J06B C11J06C C11J06D C11J12A C11J12B C11J21E C11J22F C11J29A C11J29B C11J29C C11K03E C11K06A C11K06B C11K06C F11J19A F11J29F F11K11D F11K25G F11L03A and F11L17A
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA , and the countries of Australia, Belgium, Canada, Czech Republic, France, Germany, Italy, Ireland, Japan, Netherlands, Russia, Sweden, Switzerland, United Kingdom and Venezuela.
  • Descripción del producto
    12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
  • Manufacturer
    Spectranetics Corp.
  • 1 Event

Fabricante

Spectranetics Corp.
  • Dirección del fabricante
    Spectranetics Corp., 9965 Federal Drive, Colorado Springs CO 80921-3617
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA