Device Recall Magellan Robotic Catheter System Accessory Kits

  • 모델명 / 제조번호(시리얼번호)
    Lot number 20151117
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to OH, TX. FL, CA and GA.
  • 제품 설명
    Magellan Robotic Catheter Accessory Kits, || Model number MACC 50 and MACC80. || Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
  • 제조사 모회사 (2017)
  • Source
    USFDA