Device Recall SlipCath Beacon Tip Catheter

  • 모델명 / 제조번호(시리얼번호)
    All lots of the following  Product numbers: SCBR4.0-35-150-P-NS-0,  SCBR4.0-35-65-P-NS-RC2,  SCBR4.0-38-100-P-NS-0,  SCBR4.0-38-100-P-NS-C2,  SCBR4.0-38-100-P-NS-DAV, SCBR4.0-38-100-P-NS-H1,  SCBR4.0-38-100-P-NS-HN4,  SCBR4.0-38-100-P-NS-JB1,  SCBR4.0-38-100-P-NS-JB2, SCBR4.0-38-100-P-NS-KMP,  SCBR4.0-38-100-P-NS-MAN,  SCBR4.0-38-100-P-NS-MPA,  SCBR4.0-38-100-P-NS-MPB, SCBR4.0-38-100-P-NS-SIM1,  SCBR4.0-38-100-P-NS-SIM2,  SCBR4.0-38-100-P-NS-SIM3,  SCBR4.0-38-100-P-NS-VERT, SCBR4.0-38-125-P-NS-0,  SCBR4.0-38-125-P-NS-DAV,  SCBR4.0-38-125-P-NS-JB1,  SCBR4.0-38-125-P-NS-SIM1, SCBR4.0-38-125-P-NS-SIM2,  SCBR4.0-38-125-P-NS-TEGT,  SCBR4.0-38-125-P-NS-VERT,  SCBR4.0-38-125-P-NS-VTK, SCBR4.0-38-40-P-NS-KMP,  SCBR4.0-38-65-P-NS-0,  SCBR4.0-38-65-P-NS-C2,  SCBR4.0-38-65-P-NS-KMP,  SCBR4.0-38-65-P-NS-MPA, SCBR4.0-38-65-P-NS-RIM,  SCBR4.0-38-65-P-NS-TC,  SCBR4.0-38-65-P-NS-TC-BNK,  SCBR4.0-38-65-P-NS-VERT, SCBR4.0-38-80-P-NS-RH,  SCBR4.0-38-80-P-NS-VS,  SCBR4.0-38-80-P-NS-VS1,  SCBR4.0-38-80-P-NS-VS2,  SCBR4.0-38-80-P-NS-VS3, SCBR4.1-35-65-P-NS-C2,  SCBR4.1-35-75-P-NS-CHG2.5, SCBR5.0-35-90-P-NS-RUC
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • 제품 설명
    Slip-Cath Beacon Tip Catheter. Angiographic catheter. || For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • 제조사 모회사 (2017)
  • Source
    USFDA