Device Recall Diamondback 360 Coronary Orbital Artherctomy System

  • Modelo / Serial
    107046, 106992, 106993, 106990.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
  • Descripción del producto
    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. || The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA