Device Recall SK6000 PAQ drape pouch

  • Modèle / numéro de série
    Lot # 16047 and 16046
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in states of: FL, MI, and VA.
  • Description du dispositif
    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) || The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    NOVADAQ TECHNOLOGIES INC., 8329 Eastlake Dr Unit 101, Burnaby Canada
  • Société-mère du fabricant (2017)
  • Source
    USFDA