Device Recall FlowGate Balloon Guide Catheter;

  • Modèle / numéro de série
    Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) including the states of CA, FL, GA, OR and TN.
  • Description du dispositif
    FlowGate Balloon Guide Catheter; || Manufactured by Concentric Medical, Mountain View, CA. || FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Société-mère du fabricant (2017)
  • Source
    USFDA