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510(k) Data Aggregation

    K Number
    K251485
    Device Name
    Excipio LV Prime Thrombectomy Device
    Manufacturer
    Contego Medical, Inc.
    Date Cleared
    2025-06-13

    (30 days)

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

    Contego Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Excipio LV Prime Thrombectomy Device is indicated for the nonsurgical removal of emboli and thrombi from peripheral blood vessels.
    Device Description
    The Excipio LV Prime Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The device will be sold as a sterile, single use device. The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal handle. The operator can open the braided component to a diameter that best matches the target vessel (6-16 mm in diameter). The thickness of the basket wires enhances the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.
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    K Number
    K230030
    Device Name
    Excipio SV Aspiration Catheter and Tubing
    Manufacturer
    Contego Medical, Inc.
    Date Cleared
    2023-05-30

    (145 days)

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

    Contego Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Excipio® SV Aspiration Catheter and Tubing is indicated for the non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels.
    Device Description
    The Excipio SV Aspiration Catheter and Tubing consists of an aspiration catheter which is a single, large inner lumen catheter with a hydrophilic coating (20cm outside the distal end) designed to navigate through the peripheral vasculature and provide the maximum luminal area for aspiration. The aspiration catheter will be available in 7F and 8F sizes. Sterile, single use aspiration tubing will be distributed to facilitate a vacuum connection between the aspiration catheter and the collection canister of the vacuum pump.
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