PAXWIRE Occlusion Balloon System

  • Model / Serial
    Product Model ACX101, Manufacturer UDI *+ M465ACX10106*  Lot No: F1614503
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to FL and NJ
  • Product Description
    The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    AccessClosure, Inc., A Cardinal Health Company, 5452 Betsy Ross Dr, Santa Clara CA 95054-1101
  • Manufacturer Parent Company (2017)
  • Source
    USFDA