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510(k) Data Aggregation

    K Number
    K031164
    Device Name
    PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
    Manufacturer
    Oscor Inc.
    Date Cleared
    2003-06-19

    (66 days)

    Product Code
    DTD
    Regulation Number
    870.3620
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pacing bipolar lead adaptors are indicated for connecting the existing pacing lead(s) to a compatible pacemaker header cavity.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device, specifically "Pacing Bipolar Lead Adaptors, Models iLINK". It indicates that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.

    However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The document is a regulatory approval letter, not a technical report detailing the device's validation study. Therefore, I cannot extract the requested information from this text.

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