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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K021654
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This is a 510(k) approval letter for a medical device (AIRCAST Sterile VenaFlow™ Disposable Cuff) and does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria. The provided text is a regulatory document confirming substantial equivalence, not a study report.

    Therefore, I cannot extract the requested information from the given text. It does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size, data provenance, or details about test sets.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Training set sample size.
    9. How ground truth for the training set was established.
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