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510(k) Data Aggregation

    K Number
    K984438
    Date Cleared
    1999-01-07

    (24 days)

    Product Code
    Regulation Number
    878.4300
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Modified Auto Suture* VCS** Anastomotic** clip cartridge is intended for use in the anastomosis of vascular structures and in the attachment of synthetic vascular prosthesis.

    Device Description

    The Modified Auto Suture* VCS** Anastomotic** clip cartridge uses titanium implantable clips to hold everted tissue edges together for the creation of vascular anastomosis.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or studies in the context of a medical device's analytical or clinical validation, especially not in a way that aligns with the requested format (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details). Instead, the document describes a 510(k) submission for a Modified Auto Suture* VCS** Anastomotic** Clip Cartridge, focusing on its regulatory approval process, intended use, and substantial equivalence to predicate devices.

    Therefore, I cannot fulfill your request for an acceptance criteria table and study details based on the provided text. The information required for such a response (like performance metrics, study designs, and data characteristics) is simply not present in the given document.

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