Cooltip RFA Electrode Kits

  • 모델명 / 제조번호(시리얼번호)
    ACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 168853 through, 209457X; ACT1507, 168576 through, 209455X; SWCT1530, 170383 through, 210057X; ACT1510, 170882 through , 207901X; SWCT15303, 169683 through, 207900X; ACT1520, 168571 through, 210054X; SWCT1540, 170384 through, 197330; ACT1530, 169419 through, 209547X; SWCT20303, 191407 through, 191407; ACT2020, 168854 through, 210720X; SWCT2303, 195745 through, 195745; ACT2030, 168574 through, 209453X; SWCT2530, 205456 through, 205456; ACT2530, 169684 through, 209599X; SWCT25303, 177906 through, 213729X; ACTC1025, 171300 through, 208194X; SWCT2540, 191404 through, 205455 DGPHP, 162732 through, 214867X.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.
  • 제품 설명
    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) || The product is used during ablation surgical procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA