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510(k) Data Aggregation

    K Number
    K990142
    Device Name
    HT, MODEL HT PB
    Manufacturer
    SULZER OSCOR, INC.
    Date Cleared
    1999-07-30

    (192 days)

    Product Code
    DTB
    Regulation Number
    870.3680
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The tined passive tip permanent lead is indicated for ventricular placement. The lead is used in conjunction with an implantable pulse generator. A variety of pulse generators can be used in combination with the lead. The lead will connect directly to many commercially available pulse generators. Some pulse generators require the use of a commercially available adapter to make the connection to the lead.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions you've asked.

    Therefore, I cannot extract the requested information from this document. If you can provide a document that describes the acceptance criteria and the study conducted for a device, I would be happy to analyze it and answer your questions.

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