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510(k) Data Aggregation

    K Number
    K130843
    Device Name
    SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
    Manufacturer
    Oscor Inc.
    Date Cleared
    2014-01-08

    (287 days)

    Product Code
    DRC
    Regulation Number
    870.1390
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE

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

    Indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Oscor Inc. regarding their SafeSept® NF Transseptal Trocar Guidewire. This document primarily focuses on regulatory approval and equivalence to a predicate device. It does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the input text. The document confirms the device's regulatory classification, its intended use, and that a substantial equivalence determination has been made, but it does not detail the technical performance studies that would typically include acceptance criteria and study results.

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