Devices

Device Recall AMPLATZER PFO Occluder

  • 모델명 / 제조번호(시리얼번호)
    Lot number M06B01-52, serial numbers 190477 - 190494
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
  • 제품 설명
    AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
  • Manufacturer
    AGA Medical Corporation
  • 1 Event

제조사

AGA Medical Corporation
  • 제조사 주소
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA

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

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Device Recall AMPLATZER PFO Occluder
  • 모델명 / 제조번호(시리얼번호)
    Lot number M06B01-58, serial numbers 190495 - 190512
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
  • 제품 설명
    AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
  • Manufacturer
    AGA Medical Corporation