Arstasls One Access System

  • Model / Serial
    Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Arstasis, Inc, 740 Bay Rd, Redwood City CA 94063-2469
  • Manufacturer Parent Company (2017)
  • Source
    USFDA