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510(k) Data Aggregation

    K Number
    K172716
    Device Name
    V2K Rinspiration System
    Manufacturer
    Date Cleared
    2018-01-26

    (140 days)

    Product Code
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    V2K Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The V2K Rinspiration System is intended to infuse physician specified fluids and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature.
    Device Description
    The V2K Rinspiration System is comprised of the V2K Rinspiration Catheter and two accessory components; an Infusion Syringe and a Filter Line. The V2K Rinspiration Catheter is a multi-lumen catheter that has infusion holes located near the distal end of the catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. Simultaneous infusion and aspiration can be performed through these lumens to perform fluid mechanical thrombectomy to remove fluid, fresh, soft emboli and thrombi from peripheral vasculature. The Rinspiration Catheter will be placed in the target vasculature of a patient over an 0.014" guide wire. The V2K Rinspiration Catheter uses a rapid exchange (a.k.a. rail) configuration for the guidewire lumen. The Rinspiration catheter distal tip will be positioned at the intended treatment site. Infusion occurs approximately 1 to 2cm proximal to the distal tip. The catheter includes a smaller radiopaque marker band at the distal tip and two larger radiopaque marker bands designating the infusion portion of the catheter. The catheter has a V-hub on the proximal end that allows access to the infusion and aspiration lumens. Included in the same packaging as the V2K Rinspiration Catheter is a 12cc Infusion Syringe with an attached check valve. The Infusion Syringe is intended to be used for infusing physician specified fluids through the V2K Rinspiration Catheter. The V2K Rinspiration Catheter will also be supplied with an accessory Filter Line which is intended to be used to connect the catheter to a continuous vacuum source such as an aspiration pump or hospital vacuum line. The Filter Line has two connections, one male Luer and one slip-fit connector. The male Luer is connected to the aspiration lumen of the V2K Rinspiration Catheter. The slip-fit connector is connected to the continuous vacuum source. The Filter Line also has an in-line flow control switch and an in-line filter. The in-line flow control switch is used to open/close the connection between the continuous vacuum source and the aspiration lumen of the catheter. This allows the user a simple method to manage the aspiration flow. The in-line filter is used to collect any debris that is aspirated through the catheter and allows the user to clearly visualize what has been aspirated. This also allows for temporary storage, inspection, analysis, transport and / or disposal of the aspirated materials.
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