Spectranetics Corporation

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 5 건

  • 모델명 / 제조번호(시리얼번호)
    FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
  • 제품 설명
    Bridge Occlusion Balloon. Model: 590-001 || Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.
  • 모델명 / 제조번호(시리얼번호)
    FDD16D20A; FDD16E02A; FBM16D15B; FBM16F17A; FHH16D05B; FHH16G13A FHH16D12A; FHH16G22A; FHH16D19A; FHH16H05A; FHH16D26A; FHH16H08C FHH16D27A; FHH16H12A; FHH16E03A; FHH16H15A; FHH16E13A; FHH16H17A FHH16E16A; FHH16H24A; FHH16F03A; FHH16H29A; FHH16F07A; FHH16J19A FHH16F22A ; FHH16J29A; FHH16F28A; FTT16D07A; FTT16F24A; FTT16E23A; FTT16H04A; FTT16F01A; FTT16J09A; FUU16E18A; FUU16F30A; FUU16F08A; FBB16D18A; FBB16H03A; FBB16F01A; FBB16H03B; FBB16G11A; FBB16H26A FBB16G20A; FLL16G21A; FHH16G28A; FHH16J09B
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
  • 제품 설명
    ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 || The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.
  • 모델명 / 제조번호(시리얼번호)
    FBD16D01A; FBD16F20A; FBD16D11A; FBD16F29A; FBD16D14A; FBD16G18A; FBD16D23A; FBD16G29A; FBD16E05A; FBD16H03A; FBD16E11A; FBD16H26A FBD16E19A; FBD16J06A; FBD16E26A; FBD16J21A; FBD16F03A; FBD16J26A; FBE16C30A; FBE16H24A; FBE16E25A; FBE16J14A; FBE16F15A; FAY16C29A; FAY16G14A; FAY16D08A; FAY16G29A; FAY16D26A; FAY16H23A; FAY16E17A; FAY16H31A; FAY16F08A; FAY16J23B; FAY16G01A; FBF16D27A; FBF16G07A FBF16E12A ; FBF16H10B; FBF16F17A; FBF16J16A; FAZ16C31A; FAZ16G25A; FAZ16D14A ; FAZ16H01A; FAZ16D25A; FAZ16H22A; FAZ16E06A; FAZ16H30A FAZ16F24B; FAZ16J20A; FAZ16F27A; FBG16E02A; FBG16H31A; FBG16F23A; CBA16H19A; FBA16F27A; CBA16H19B; FBA16G11A; CBA16H19C; FBA16G15A; FBA16D04A; FBA16G19A; FBA16D06A; FBA16G27B; FBA16D18A; FBA16H02A FBA16D21A; FBA16H08A; FBA16E09A; FBA16H17A; FBA16E10A; FBA16J02A FBA16E13A; FBA16J07A; FBA16E19A; FBA16J19A; FBA16F07A; FBA16J22A; FBA16F21A; FBE16E02A; FBE16G06A; FBE16G20A; FAZ16E26A; FAZ16G12A; FBA16D29A; FBA16F16B;
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
  • 제품 설명
    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 || The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.
  • 모델명 / 제조번호(시리얼번호)
    Model Number 590-001, Lots FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN47D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and United Kingdom.
  • 제품 설명
    Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. || Product Usage: || It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
  • 모델명 / 제조번호(시리얼번호)
    Model Number 414-159 Catheter Diameter 1.4mm,  Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands
  • 제품 설명
    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters || Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 11 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 모회사 (2017)
  • Source
    MSHM
  • 제조사 모회사 (2017)
  • Source
    FSSH
  • 제조사 모회사 (2017)
  • Source
    LAANSM
  • 제조사 모회사 (2017)
  • Source
    BAM
  • 제조사 주소
    Spectranetics Corporation, 96 Talamine Ct, Colorado Springs CO 80907-5159
  • 제조사 모회사 (2017)
  • Source
    USFDA
하나 더 6 건 더