Spectranetics Corp.

  • 제조사 주소
    Spectranetics Corp., 9965 Federal Dr, Colorado Springs CO 80921-3617
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 1 Event

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 1 건

  • 모델명 / 제조번호(시리얼번호)
    Lot CMP15J28A
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution to Florida, North Carolina and Pennsylvania.
  • 제품 설명
    2.3mm Turbo-Power OTW, Manual, Model No 423-050 || Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 모회사 (2017)
  • Source
    AEMPSVFOI
  • 제조사 주소
    Spectranetics Corp., 9965 Federal Drive, Colorado Springs CO 80921-3617
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 모회사 (2017)
  • Source
    DMA
  • 제조사 모회사 (2017)
  • Source
    RLMPH