Device Recall Edwards Lifesciences Crimpers

  • Modèle / numéro de série
    Models 9100CR26, all lot numbers.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    Edwards Lifesciences Crimpers, Model 9100CR26. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Société-mère du fabricant (2017)
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Models 9100CR23, all lot numbers.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    Edwards Lifesciences Crimpers, Model 9100CR23. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
  • Manufacturer