Device Recall EMPIRA (TM) RX PTCA Dilatation Catheter

  • 모델명 / 제조번호(시리얼번호)
    70 Catalog numbers:  85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S,  85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S, 85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S, 85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S, 85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S, 85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S, 85R25275S, 85R25300S, 85R25325S, 85R25350S, 85R25375S, 85R25400S, 85R30150S, 85R30200S, 85R30225S, 85R30250S, 85R30275S, 85R30300S 85R30325S, 85R30350S, 85R30375S, and 85R30400S.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.
  • 제품 설명
    Cordis EMPIRA RX PTCA Dilatation Catheter
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • 제조사 모회사 (2017)
  • Source
    USFDA