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510(k) Data Aggregation

    K Number
    K993139
    Device Name
    YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
    Manufacturer
    BIOTRONIK, INC.
    Date Cleared
    1999-12-17

    (88 days)

    Product Code
    DTB
    Regulation Number
    870.3680
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K990483,K910608,K873888
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BIOTRONIK's YP xx/15-BP leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators. The leads may be used with single or dual chamber pacing systems. The YP xx/15-BP lead models are intended for placement in either the patient's right atrium or right ventricle.

    Device Description

    BIOTRONIK's YP xx/15-BP leads are transvenous, bipolar, active fixation, endocardial pacing leads. The lead conductor is quadrifilar MP35N wire in a coaxial configuration, insulated with silicone tubing, and electrodes surfaces with a fractal iridium surface treatment. The leads are available in 45, 53, and 60 cm lenaths and have IS-1 connectors.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for a medical device (an active fixation endocardial lead), not a study report. It does not contain information on acceptance criteria, device performance, sample sizes used, ground truth establishment, or any comparative effectiveness studies. Therefore, it is impossible to extract the requested information from this document.

    The document primarily focuses on:

    • Device Description: General characteristics, materials, and predicate devices.
    • Indications for Use: What the device is intended for.
    • Regulatory Information: Classification, manufacturing site, and contact details.

    To answer your questions, a study report detailing the device's performance against specific criteria would be needed.

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