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

  • Modèle / numéro de série
    RSC01
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Société-mère du fabricant (2017)
  • Source
    USFDA