Device Recall Diamondback 360 Coronary Orbital Artherctomy System

  • 모델명 / 제조번호(시리얼번호)
    107046, 106992, 106993, 106990.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
  • 제품 설명
    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. || The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • 제조사 모회사 (2017)
  • Source
    USFDA