Turbo Elite Atherectomy Catheter

  • Model / Serial
    FBD16D01A; FBD16F20A; FBD16D11A; FBD16F29A; FBD16D14A; FBD16G18A; FBD16D23A; FBD16G29A; FBD16E05A; FBD16H03A; FBD16E11A; FBD16H26A FBD16E19A; FBD16J06A; FBD16E26A; FBD16J21A; FBD16F03A; FBD16J26A; FBE16C30A; FBE16H24A; FBE16E25A; FBE16J14A; FBE16F15A; FAY16C29A; FAY16G14A; FAY16D08A; FAY16G29A; FAY16D26A; FAY16H23A; FAY16E17A; FAY16H31A; FAY16F08A; FAY16J23B; FAY16G01A; FBF16D27A; FBF16G07A FBF16E12A ; FBF16H10B; FBF16F17A; FBF16J16A; FAZ16C31A; FAZ16G25A; FAZ16D14A ; FAZ16H01A; FAZ16D25A; FAZ16H22A; FAZ16E06A; FAZ16H30A FAZ16F24B; FAZ16J20A; FAZ16F27A; FBG16E02A; FBG16H31A; FBG16F23A; CBA16H19A; FBA16F27A; CBA16H19B; FBA16G11A; CBA16H19C; FBA16G15A; FBA16D04A; FBA16G19A; FBA16D06A; FBA16G27B; FBA16D18A; FBA16H02A FBA16D21A; FBA16H08A; FBA16E09A; FBA16H17A; FBA16E10A; FBA16J02A FBA16E13A; FBA16J07A; FBA16E19A; FBA16J19A; FBA16F07A; FBA16J22A; FBA16F21A; FBE16E02A; FBE16G06A; FBE16G20A; FAZ16E26A; FAZ16G12A; FBA16D29A; FBA16F16B;
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
  • Product Description
    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 || The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Spectranetics Corporation, 9965 Federal Drive, Colorado Springs CO 80921-3617
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    Injections / Infusions / Transfusions / Dialysis - catheters
  • Manufacturer