Device Recall AMPLATZER Exchange Systems

  • 모델명 / 제조번호(시리얼번호)
    M02B14-09, M02C25-16
  • 유통
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • 제품 설명
    AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • 1 Event

제조사

  • 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 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    M01L12-10, M03D08-06, M03D08-07, M03L18-54
  • 유통
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • 제품 설명
    AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    M01B14-8, M02F05-18, M03A09-69, M03E27-05, M03F18-12
  • 유통
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • 제품 설명
    AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    M02A28-25, M04D01-06
  • 유통
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • 제품 설명
    AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer