Device Recall Percutaneous Insertion Tray

  • 모델명 / 제조번호(시리얼번호)
    Batch: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
  • 제품 설명
    Percutaneous Insertion Tray; Product Code: IAK-S7IT || The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
  • Manufacturer
  • 2 Events

제조사

  • 제조사 주소
    Arrow International, Inc., Division of Teleflex Medical Inc., 9 Plymouth St, Everett MA 02149-1814
  • 제조사 모회사 (2017)
  • Source
    USFDA