LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080174
    Device Name
    PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C
    Manufacturer
    CARDIOMED SUPPLIES, INC.
    Date Cleared
    2008-04-23

    (90 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CMS Phlebotomy Bag Sets are described as devices intended to control the collection and disposal of blood, from a peripheral vein and into a container( bag) for safe removal and disposal.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding CardioMed (CMS) Phlebotomy Bag Sets. This type of document is a regulatory approval letter based on substantial equivalence to a predicate device, not a study report detailing acceptance criteria and device performance evaluation.

    Therefore, the document does not contain the information requested regarding acceptance criteria, device performance results, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

    This letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It does not elaborate on the specific performance data or studies that led to this determination beyond the statement of equivalence.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1