Device Recall Stryker brand Neuroform 3 Microdelivery Stent System

  • Modèle / numéro de série
    Code: M003450200, Lot 15391019, Expiration Date: 2015-07
  • Classification du dispositif
  • Classe de dispositif
    HDE
  • Dispositif implanté ?
    Yes
  • Distribution
    International Distribution including Austria, China, and Germany.
  • Description du dispositif
    Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA || The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Société-mère du fabricant (2017)
  • Source
    USFDA