CryoCath

  • 모델명 / 제조번호(시리얼번호)
    Lots 02-0464; 02-0474; 02-0578; 02-0711; 02-0852; 02-0911; 02-0981; 02-0982
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was sent only to one Canadian distribution company whoin turn sold it internationally and back to the USA.
  • 제품 설명
    SurgiFrost Cryosurgical Probes
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Endocare Inc, 201 Technology Drive, Irvine CA 92618
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical electronics / Electromedical devices
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Number: 2AF282 Lot Numbers: 21571, 25375, 25376, 25377, and 25381
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MN, MS, MO, NE, NY, NC, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI. and the countries of: Austria, United Kingdom.
  • 제품 설명
    Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) || Product Usage: The Medtronic CryoCath System consists of a Cryoablation console, cardiac Cryoablation catheters, connection components and accessories. The Arctic Front Cardiac Cryoablation Catheter is an over the wire Balloon catheter. The inside of the Balloon at the distal end of the Cryoablation Catheter reaches temperatures of -50¿C or colder when refrigerant is injected from the console to the inside of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced into the vasculature by traditional minimally invasive techniques. The CryoConsole houses the electrical and mechanical components as well as proprietary software for controlling and recording a cryotherapy procedure with Arctic Front and/or the Freezor family of catheters. It stores and controls the delivery of the liquid refrigerant through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheter and the CryoConsole system to ensure safety.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    CryoCath Arctic Front Cryoablation system
  • Manufacturer