Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K112838
    Device Name
    VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Date Cleared
    2011-11-10

    (43 days)

    Product Code
    JOW, PRO
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPRESSION THERAPY CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DVT Garment is an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
    Device Description
    The VasoPress Reprocessed DVT Leg Garment consists of a brushed nylon outer material bonded to a foam inner liner bonded to a tricot lining. An inflatable polyvinylchloride (PVC) pressure bag is encapsulated between an additional nylon/foam material. The VasoPress Reprocessed DVT Foot Garment has the same outer shell with a polyurethane (PU) pressure bag inside. An exit tube leads out from the pressure bag for connection to the VasoPress Pump. The device is automatically inflated by a pneumatic pump. The patient contact material is tricot over polyurethane foam. The reprocessed devices are cleaned, inspected and tested, packaged and exposed to Ethylene Oxide (EO) gas wash. The VasoPress Reprocessed DVT Garments are provided non-sterile.
    Ask a Question
    K Number
    K101915
    Device Name
    VASOPRESS SUPREME MINI MODEL VP500DM
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Date Cleared
    2010-08-06

    (28 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPRESSION THERAPY CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
    Device Description
    VasoPress DVT Supreme Mini, Pump Model No. VP500DM
    Ask a Question
    K Number
    K061814
    Device Name
    VASOPRESS DVT SYSTEM, MODEL VP500D
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Date Cleared
    2006-11-30

    (156 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPRESSION THERAPY CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasoPress pump (VP500D) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
    Device Description
    VasoPress DVT System, Pump Model VP500D
    Ask a Question
    K Number
    K061967
    Device Name
    SCD GARMENT, MODEL VP530
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Date Cleared
    2006-09-25

    (75 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPRESSION THERAPY CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
    Device Description
    Not Found
    Ask a Question
    K Number
    K000147
    Device Name
    CTC DVT-1 CALF GARMENT, MODEL DVT-1
    Manufacturer
    COMPRESSION THERAPY CONCEPTS, INC.
    Date Cleared
    2000-04-13

    (86 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPRESSION THERAPY CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1