Device Recall Spectranetics TurboElite Laser Atherectomy Catheters

  • Modèle / numéro de série
    Model Number 414-159 Catheter Diameter 1.4mm,  Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands
  • Description du dispositif
    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters || Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Spectranetics Corporation, 9965 Federal Drive, Colorado Springs CO 80921-3617
  • Société-mère du fabricant (2017)
  • Source