PERIPHERAL CUTTING BALLOON

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: (Lot serial: CATALOG # BP135710B); Model Catalog: (Lot serial: CATALOG # BP907010B); Model Catalog: (Lot serial: CATALOG # BP507010B); Model Catalog: (Lot serial: CATALOG # BP135610B); Model Catalog: (Lot serial: CATALOG # BP906010B); Model Catalog: (Lot serial: CATALOG # BP505010B); Model Catalog: (Lot serial: CATALOG # BP1355510B); Model Catalog: (Lot serial: CATALOG # BP905510B); Model Catalog: (Lot serial: CATALOG # BP505510B); Model Catalog: (Lot serial: CATALOG # BP1355010B); Model Catalog: (Lot serial: CATALOG # BP905010B); Model Catalog: (Lot serial: CATALOG # BP506010B)
  • 제품 설명
    1CM PERIPHERAL CUTTING BALLOON
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    MISSISSAUGA
  • 제조사 모회사 (2017)
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    HC

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 14 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    4.0mm x15mm Small Peripheral Cutting Balloon (Monorail & Over-the-Wire ) Microsurgical Dilatation Device (used for Percutaneous Transluminal Angioplasty of obstructive lesions in peripheral vessels) and 4.00mm x15mm Flextome Cutting Balloon (Monorail & Over-the-Wire) Microsurgical Dilatation Device (used in patients with coronary vessel disease) Multiple catalogue numbers and lot numbers Expiration Date Range: 16-Nov-2015 to 03-Jun-2016ARTG Numbers: 168036 and 169861
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. Singapore South Africa Spain Sweden Switzerland & Turkey
  • 제품 설명
    The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.
  • Manufacturer
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