Device Recall AtriCure Reusable Clip Applier

  • Modèle / numéro de série
    Lot Number MFR-0424-1
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.
  • Description du dispositif
    Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. || The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Atricure Inc, 6217 Centre Park Drive, West Chester OH 45069
  • Société-mère du fabricant (2017)
  • Source
    USFDA