BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    PMA: P810046 · Supplement: S186 · Decision Mar 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70

    Basic Information

    Device Name
    Catheters, Transluminal Coronary Angioplasty, Percutaneous
    Trade Name
    ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE CATHETER
    PMA Number
    P810046
    Supplement Number
    S186
    Device Class
    FDA Class 2
    Product Code
    LOX
    Generic Name
    Catheters, transluminal coronary angioplasty, percutaneous
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 13, 1998
    Date Received
    January 23, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for ACS Swap-It(TM) Guide Wire Exchange Device which is an accessory to Guidant ACS RX (Rail) catheters. This device will be marketed under the trade name ACS Swap-It(TM) Guide Wire Exchange Device and is indicated for use within a guiding catheter to facilitate the exchange of a 0.014 inch guide wire while maintaining the position of an ACS RX(R) (Rail) catheter.

    Classifications

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

    Product Code Device Name
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous