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510(k) Data Aggregation

    K Number
    K251982
    Date Cleared
    2025-09-23

    (88 days)

    Product Code
    Regulation Number
    870.3800
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

    Device Description

    The Edwards MC3 Tricuspid annuloplasty ring, model 4900, consists of two primary components: the implantable annuloplasty ring and the template/ lanyard assembly (or holder). The implantable annuloplasty ring is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber, covered with polyester velour cloth sewn with a single seam.

    The Edwards MC3 Tricuspid annuloplasty ring can be used in tricuspid valve repairs. The oval tricuspid ring conforms to the configuration of a normal tricuspid orifice. The ring has one rectilinear segment corresponding to the septal leaflet and one long curved segment corresponding to the anterior and posterior leaflets. The ring is open at the anteroseptal commissure. The annuloplasty ring is provided on an integral template which holds the ring during the plication to the annulus. A feature of the Edwards MC3 Tricuspid annuloplasty ring is that the rigid template is designed not to interfere with the tying of sutures and contains a retrieval system during the removal process. After implantation, this rigid template is removed.

    The model 1150 handle may be utilized to facilitate ease of suture placement and annuloplasty ring implantation. The snap-fit assembly of the handle and template/lanyard assembly allows for connecting and disconnecting of the two components.

    AI/ML Overview

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