Devices

Device Recall SMARTABLATE System

  • 모델명 / 제조번호(시리얼번호)
    Product Codes M490006, M490007
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distributed to the following states: CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI. Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.
  • 제품 설명
    SMARTABLATE RF System Generator
  • Manufacturer
    Biosense Webster, Inc.
  • 1 Event

제조사

Biosense Webster, Inc.
  • 제조사 주소
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA