Device Recall Pinnacle Destination Guiding Sheath, 6 French, 90 cm

  • 모델명 / 제조번호(시리얼번호)
    RSC01
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama
  • 제품 설명
    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • 제조사 모회사 (2017)
  • Source
    USFDA