Device Recall TriActiv System Procedure Kit 340 cm

  • Modèle / numéro de série
    Lot number 47303 exp 9/30/06
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. The products are shipped to hospitals in AL, DE, Fl, IL, IN, MI, PA, SC, TN and TX.
  • Description du dispositif
    TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using femoral approach.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341-1130
  • Source
    USFDA