Device Recall Stent Delivery Catheter

  • Modèle / numéro de série
    Device Codes: S-04-120-120-G3 (Lot Number 05180062); S-04-040-120-G3 (Lot Numbers 05180031); S-04-060-120-G3 (Lot Number 05187032); S-05-040-120-G3 (Lot Number 05180034); S-05-060-120-G3 (Lot Number 05180035); S-05-080-120-G3 (Lot Number 05180036); S-05-100-120-G3 (Lot Number 05180037); and S-06-080-120-G3 (Lot Number 05180042).
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-USA (nationwide) including the states of AL, IL, NJ, NV, and PA.
  • Description du dispositif
    SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. || Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Idev Technologies, Inc., 253 Medical Center Blvd, Webster TX 77598
  • Source
    USFDA