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510(k) Data Aggregation

    K Number
    K034010
    Device Name
    GELSOFT PLUS ERS
    Manufacturer
    VASCUTEK LTD.
    Date Cleared
    2004-02-19

    (57 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K202703
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EXTRA-ANATOMICAL VASCULAR REPAIR PRIMARILY FOR AXILLO-FEMORAL/BIFEMORAL BYPASS AND FEMORO-POPLITEAL RECONSTRUCTION

    Device Description

    VASCUTEK GELSOFT PLUS ERS VASCULAR GRAFT

    AI/ML Overview

    The provided documents are a letter from the FDA regarding a 510(k) premarket notification for the "Vascutek Ltd. Gelsoft Plus ERS" vascular prosthesis, and an "Indications for Use" statement. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

    The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It focuses on regulatory compliance rather than providing detailed study data.

    To answer your request, I would need a different set of documents, specifically those related to the performance studies conducted for the Vascutek Gelsoft Plus ERS vascular graft.

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