Device Recall AVANTI Catheter Sheath Introducer System

  • Modèle / numéro de série
    Catalog No. 504656X (GTIN: 20705032010389) Lot No. 17305580, Expiration date: 2018-07-31.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.
  • Description du dispositif
    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM || The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Société-mère du fabricant (2017)
  • Source
    USFDA