Device Recall Maverick 2" Monorail PTCA Catheter

  • 모델명 / 제조번호(시리얼번호)
    Lots: 6240888, Exp January 2007; 6240363, Exp January 2007.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.
  • 제품 설명
    Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-1225 || Use before 2007-01 || UPN H7493892812250 || Sterilized with ethylene oxide gas || Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-2035 || Use before 2007-01 || UPN H7493892820350 || Sterilized with ethylene oxide gas || Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA