Cardiovascular Systems, Inc.

4 dispositivos en la base de datos

  • Modelo / Serial
    100573, 100575, 100674, 100676, 100678, 100680.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.
  • Descripción del producto
    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. || The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
  • Modelo / Serial
    Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
  • Descripción del producto
    CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 || Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
  • Modelo / Serial
    Lot s: 59887, 59888, 61516, and 61517.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
  • Descripción del producto
    CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. || The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
  • Modelo / Serial
    107046, 106992, 106993, 106990.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
  • Descripción del producto
    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. || The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

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Más información acerca de la data acá

  • Dirección del fabricante
    Cardiovascular Systems, Inc., 651 Campus Dr, Arden Hills MN 55112-3495
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA