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510(k) Data Aggregation

    K Number
    K024019
    Device Name
    ARTERIALFLOW SYSTEM, MODEL 32A
    Manufacturer
    AIRCAST, INC.
    Date Cleared
    2003-06-03

    (180 days)

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

    AIRCAST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the improvement of blood circulation in the upper and lower extremities to help prevent and reduce complications of poor circulation.
    Device Description
    Not Found
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    K Number
    K023800
    Device Name
    VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
    Manufacturer
    AIRCAST, INC.
    Date Cleared
    2003-02-10

    (88 days)

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

    AIRCAST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prophylaxis for DVT (Deep Vein Thrombosis)
    Device Description
    VenaFlow Reusable Calf Aircell
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    K Number
    K992454
    Device Name
    VENAFLOW SYSTEM, MODEL 30A
    Manufacturer
    AIRCAST, INC.
    Date Cleared
    2000-01-13

    (174 days)

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

    AIRCAST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prophylaxis for Deep Vein Thrombosis (DVT)
    Device Description
    Not Found
    Ask a Question
    K Number
    K964238
    Device Name
    AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS
    Manufacturer
    AIRCAST, INC.
    Date Cleared
    1997-09-08

    (320 days)

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

    AIRCAST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Same as the predicate device. The cuff is a part of the VenaFlow System. Indication for use is as a prophylaxis for DVT (Deep Vein Thrombosis).
    Device Description
    Aircast Venaflow Sterile Disposable Cuff
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    K Number
    K961676
    Device Name
    AIRCAST VENAFLOW SYSTEM (MODIFICATION)
    Manufacturer
    AIRCAST, INC.
    Date Cleared
    1997-03-28

    (350 days)

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

    AIRCAST, INC.

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

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