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510(k) Data Aggregation

    K Number
    K253671

    Validate with FDA (Live)

    Date Cleared
    2026-01-30

    (70 days)

    Product Code
    Regulation Number
    870.4210
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dual Stage Venous Return Cannula is indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery for up to six hours.

    Device Description

    Dual Stage Venous Return Cannulae are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

    The devices are composed of the cannula: an open lumen PVC polymer tube incorporating wire reinforcement in distal section. In some models is present a malleable obturator inserted into the cannula to allow the placement of the cannula along the vein. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the venous line.

    The distal end of the cannula has a lighthouse-shaped tip, allowing the venous blood to flow from the vessel into the cannula, in addition the distal sections of the cannula are perforated with multiple holes at multiple stages to better allow the fluid flows from outside into the cannula body. The clear proximal section is not reinforced to allow clamping; the proximal end typically does not have any pre-mounted connector and can accommodate a barbed connector for standard cardiopulmonary bypass tubing (½" diameter). In some models a pre-mounted 1/2" barbed connector is present.

    The following cannula models are available:

    Device trade nameModelFrench size (Outside diameter)Characteristics
    Dual Stage Venous CannulaeRDS-61040Proximal: 40 Fr Distal: 32 Fr.Without connector
    Dual Stage Venous CannulaeRDS-61034Proximal: 46 Fr Distal: 34 Fr.Without connector
    Dual Stage Venous CannulaeRDS-61046Proximal: 46 Fr Distal: 36 Fr.Without connector
    Dual Stage Venous CannulaeRDS-61050Proximal: 50 Fr Distal: 36 Fr.Without connector
    Dual Stage Venous CannulaeRDS-61140Proximal: 40 Fr Distal: 32 Fr.With connector
    Dual Stage Venous CannulaeRDS-61134Proximal: 46 Fr Distal: 34 Fr.With connector
    Dual Stage Venous CannulaeRDS-61146Proximal: 46 Fr Distal: 36 Fr.With connector
    Dual Stage Venous CannulaeRDS-61150Proximal: 50 Fr Distal: 36 Fr.With connector

    The Dual Stage Venous Return Cannulae are the modified version of the disposables currently marketed under K943934.

    Both modified and unmodified cannulae models are recommended for use as Venous cannula during cardiopulmonary bypass up to six hours.

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