Device Recall Lumen Biomedical Xtract Aspiration Catheter system

  • 모델명 / 제조번호(시리얼번호)
    Part number 1450-001 size 4.2F and 1451-003 size 5.8F, all lots.
  • 의료기기 분류등급
  • 유통
    Worldwide distribution: USA, Greece, Egypt, Kuwait, Netherlands, Saudi Arabia, Italy, France, Sweden, Portugal, Great Britain, Austria, Switzerland, Germany, Romania, Poland, and Bulgaria
  • 제품 설명
    Lumen Biomedical Xtract Aspiration Catheter system, intravascular catheter, consisting of One Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One 40 um Cell Strainer. Single-user, 0.014" guidewire compatible intravascular extraction and aspiration catheter, Part number 1450-0001 size 4.2F, and part number 1451-003 size 5.8F, distributed by Volcano Corporation.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • 제조사 모회사 (2017)
  • Source
    USFDA