Arstasls One Access System

  • Modèle / numéro de série
    Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft || and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CA || The Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is Indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F Introducer sheaths.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Arstasis, Inc, 740 Bay Rd, Redwood City CA 94063-2469
  • Société-mère du fabricant (2017)
  • Source
    USFDA