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510(k) Data Aggregation

    K Number
    K990390
    Device Name
    HEPARIN IV FLUSH SYRINGE, 10 U/ML \
    Manufacturer
    ROCAP DIV. OF SABRATEK CORP.
    Date Cleared
    1999-12-10

    (304 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 10 U/mL is indicated for use to maintain patency of indwelling venous access devices.

    Device Description

    Heparin Flush Syringe, 10 U/mL

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Heparin IV Flush Syringe. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. The letter only states that the device is substantially equivalent, allowing it to be marketed. There are no details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    Therefore, I cannot provide the requested information from the provided text.

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