FIBERNET Embolic Protection System

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • 제조사 대표
    Tamer Frères S.A.L.
  • Source
    RLMPH

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    US Model Number FBC350500190, lot number 1E029174; Internation Model number FBN350500190; lot 1E012912.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
  • 제품 설명
    FIBERNET Embolic Protection System: || Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) || Rx only, Sterile; || Manufactured in: || Invatec S.P.A., Italy; || Manufacturer: || Medtronic Inc. || Minneapolis, MN. || The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    US Model Number FBC 500600190, lot number 1E029176; International Model Number FBN500600190, lot number 1E012914.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
  • 제품 설명
    FIBERNET Embolic Protection System: || Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: || 0.014 in (0.36mm) || Rx only, Sterile; || Manufactured in: || Invatec S.P.A., Italy; || Manufacturer: || Medtronic Inc. || Minneapolis, MN. || The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
  • 제품 설명
    FIBERNET Embolic Protection System: || Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: || 0.014 in (0.36mm) || Rx only, Sterile; || Manufactured in: || Invatec S.P.A., Italy; || Manufacturer: || Medtronic Inc. || Minneapolis, MN. || The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
  • Manufacturer