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510(k) Data Aggregation

    K Number
    K990308
    Device Name
    ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
    Manufacturer
    ROCAP DIV. OF SABRATEK CORP.
    Date Cleared
    1999-12-10

    (312 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    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 ROCAP Heparin Flush Syringe 100 U/mL is indicated for use to maintain patency of indwelling venous access devices.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Heparin IV Flush Syringe). It does not contain information on acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. This type of information is usually found in a separate study report or regulatory submission document.

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