Devices

Device Recall Dolphin Inflation Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 15125173
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to MD, NY, and IL
  • 제품 설명
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, || Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
  • Manufacturer
    DeRoyal Industries Inc
  • 1 Event

제조사

DeRoyal Industries Inc
  • 제조사 주소
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • 제조사 모회사 (2017)
    Deroyal Industries Inc.
  • Source
    USFDA