BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P980037 · Decision Mar 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER
    PMA Number
    P980037
    Device Class
    FDA Class 3
    Product Code
    MCX
    Generic Name
    CATHETER, CORONARY, ATHERECTOMY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 12, 1999
    Date Received
    September 14, 1998
    Expedited Review
    Y
    Docket Number
    99M-2015

    Advisory Committee Statement

    Approval for the AngioJet(R) Rheolytic(TM) Thrombectomy system (AngioJet(R) Drive Unite, AngioJet(R) Pump Set, and AngioJet(R) Rheolytic(TM) Thrombectomy LF140 Catheter). This device is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or saphenous vein graft lesion in vessels > 2.0mm in diameter prior to balloon angioplasty or stent placement.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MCX Catheter, Coronary, Atherectomy