Device Recall CORDIS S.M.A.R.T. Control" Nitinol Stent System

  • Modèle / numéro de série
    10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution --- including USA and countries of Japan and Canada.
  • Description du dispositif
    CORDIS S.M.A.R.T.¿ Control" Nitinol Stent System || Model Number(s): C10040SL, Manufactured in Mexico. || Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease.
  • Manufacturer
  • 1 Event

Fabricant

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