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510(k) Data Aggregation

    K Number
    K253354

    Validate with FDA (Live)

    Date Cleared
    2026-02-12

    (135 days)

    Product Code
    Regulation Number
    884.6110
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Minvitro Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.

    Device Description

    Minvitro Embryo Transfer Catheters are sterile single-use catheters used to place in vitro fertilized embryos into the uterine cavity. All the models of Minvitro Embryo Transfer Catheters have a transfer catheter and a guide catheter. A stylet is an optional accessory for specific models.

    The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity. Two versions of guide catheters are provided:

    • ETCA23175 series: Straight echogenic guide, with catheter shaft detectable under ultrasound to aid in catheter placement.
    • ETCB20175 series: Pre-curved guide with a bulb tip and an adjustable positioner to facilitate proper positioning.

    The transfer catheter is loaded with embryos and inserted into the guide catheter. Embryos are delivered into the uterine cavity by pressing a syringe (not provided with the catheters) connected to the transfer catheter's hub. The transfer catheter features a reinforced stainless steel support tube, with graduation marks printed on its proximal shaft. Variations with an additional echotip at the end of transfer catheter are offered for specific models (ETCB20175-ET and ETCB20175-ET-C) to assist visualization under ultrasound.

    The stylet is an optional accessory for specific models. It is a malleable plastic-coated stainless steel core, which is used to provide additional rigidity and support during guide catheter insertion.

    AI/ML Overview

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