Boston Scientific Scimed

11 dispositivos en la base de datos

  • Modelo / Serial
    all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Throughout United States and into 15 other countries.
  • Descripción del producto
    RunWay 6F Cardiovascular Guide Catheter.
  • Modelo / Serial
    Lot numbers: 7129578 and 7124116
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA and WI
  • Descripción del producto
    Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd., Cork, Ireland. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Titanium Greeenfield Vena Cava Filter comes preloaded in a jugular or a femoral introducer catheter.
  • Modelo / Serial
    Lot numbers: 7132606, 7132607, 7132608, 7133116, 7136847, 7136848, 7142615, 7142616 and 7147508
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA and WI
  • Descripción del producto
    Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M001505010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd., Cork, Ireland. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Stainless Steel Greeenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4.0 mm jugular or femoral introducer catheter.
  • Modelo / Serial
    Lot Numbers:  7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The product was distributed to hospitals nationwide.
  • Descripción del producto
    PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, || M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
  • Modelo / Serial
    UPN # H7493894886070, lot # 6412353
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates
  • Descripción del producto
    Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The stent is constrained within a 6F delivery system. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. An inner shaft, with two radiopaque markers, aids in the placement of the stent. The delivery system is compatible with 0.035 in. (0.89mm) guidewires. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. As the stent is exposed to body temperature it expands to appose the duct wall.
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Más información acerca de la data acá

  • Dirección del fabricante
    Boston Scientific Scimed, One Scimed Place, Maple Grove MN 55311-1566
  • Source
    USFDA
  • Dirección del fabricante
    MAPLE GROVE
  • Source
    HC