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    K Number
    K040163
    Device Name
    MICROVASCULAR ANASTOMOTIC DEVICE
    Manufacturer
    SYNOVIS MICRO COMPANIES ALLIANCE, INC.
    Date Cleared
    2004-04-16

    (81 days)

    Product Code
    MVR
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K861985
    Why did this record match?
    Device Name :

    MICROVASCULAR ANASTOMOTIC DEVICE

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

    The Microvascular Anastomotic COUPLER is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.

    Device Description

    The device is a sterile (gamma irradiation), single-use, implantable pair of rings molded out of high density polyethylene with six stainless steel pins on each of the ring. A probe-holder feature is molded on each of the paired rings to be a point of attachment for a sensor/probe at the site of anastomosis.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Microvascular Anastomotic Coupler and does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

    The document outlines the device's indications for use, technological comparison to a predicate device (GEM Microvascular Anastomotic Coupler; K861985), and asserts substantial equivalence in terms of biocompatibility, manufacturing, performance, sterilization, shelf life, packaging, safety, and efficacy to the predicate device.

    Therefore, I cannot provide the requested information from the given text.

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