Device Recall XACT Carotid Stent System

  • Modèle / numéro de série
    Lot Number: 9011951
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide: GA, NY, IN, LA, MA and PA
  • Description du dispositif
    Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) || The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    Lot Number: 9020551
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide: GA, NY, IN, LA, MA and PA
  • Description du dispositif
    Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) || The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease.
  • Manufacturer