Device Recall Percutaneous Catheter

  • Modèle / numéro de série
    559450, 551750, 552370, 552761, 552840, 552954, 553267, 553647, 553931, 554269, 554270, 554413. 555958, 557192, 557824, 558222, 558894, 559827, 560215, 551751, 552371, 552841, 553090, 553218, 553434, 553529, 554029,  554268, 554271, 555759, 555953, 557251, 559570, 559981, 560253, 560079,  560080, 554123, 556182, 558905, 560114, 554210, 555991, 556842, 557253, 554209, 555223, 555992, 556536, 556747, 557124, 558327, 558991, 560115, 561206, 554208, 555490, 555993, 556674, 556843, 558018, 558798, 559707, 560433, 561207, 554040, 555007, 555224, 555358, 558542, 560434, 561459, 554122, 555008, 555225, 555994, 558992, 561208, 560221, 560222, 560223, 560995, 560996.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
  • Description du dispositif
    Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. || Product Usage: || The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Société-mère du fabricant (2017)
  • Source
    USFDA