Device Recall Dolphin Inflation Device

  • Modèle / numéro de série
    Lot Number 15125173
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to MD, NY, and IL
  • Description du dispositif
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, || Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Société-mère du fabricant (2017)
  • Source
    USFDA