Device Recall Coronary sinus catheter

  • Modelo / Serial
    Lot No.: 666556, 669235, 678238, 751043, 755821, 763122
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || The Steerable Coronary Sinus Catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Edwards Lifesciences Llc, 12050 Lone Peak Parkway, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA