Device Recall Concentric 7F Balloon Guide Catheter

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 33367 and 33407
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland
  • 제품 설명
    Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA || Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • 제조사 모회사 (2017)
  • Source
    USFDA