Concentric Medical Inc

6 dispositivos en la base de datos

  • Modelo / Serial
    Lot numbers 33367 and 33407
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland
  • Descripción del producto
    Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA || Product is 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. Not intended for use to deliver embolic agents or to perform angioplasty.
  • Modelo / Serial
    Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, IN, PA, AL, and NJ.
  • Descripción del producto
    Trevo Pro 4 Stent Retriever, || Model number 80021; || U.S. Indications for use: The Trevo Retriever is intended to restore blood || flow in the neurovasculature by removing thrombus in patients experiencing || ischemic stroke within 8 hours of symptom onset. Patients who are ineligible || for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA || therapy are candidates for treatment.
  • Modelo / Serial
    Model Number 90109; Lot number 35695
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of PA, CA, TX, NM, and OH.
  • Descripción del producto
    Merci Retriever || Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
  • Modelo / Serial
    Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (nationwide) including the states of CA, FL, GA, OR and TN.
  • Descripción del producto
    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.
  • Modelo / Serial
    Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
  • Descripción del producto
    Distal Access Catheter: || Model Numbers: 90121, 90130, 90131, 90160. || The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
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  • Empresa matriz del fabricante (2017)
  • Source
    BAM