Device Recall Diamondback 360, CSI ViperWire

  • 모델명 / 제조번호(시리얼번호)
    Lot: P1406641
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system.
  • Manufacturer
  • 1 Event

제조사

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