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510(k) Data Aggregation

    K Number
    K241362
    Device Name
    Pounce XL Thrombectomy System (PTS-1011-7F135)
    Manufacturer
    Surmodics Inc.
    Date Cleared
    2024-09-11

    (120 days)

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

    Surmodics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
    Device Description
    The Surmodics™ Pounce™ XL Thrombectomy System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the peripheral arterial vasculature. The system is comprised of three separate components: a delivery catheter, a basket wire and a funnel catheter. The system also includes a basket loading tool accessory for loading the basket wire into the delivery catheter. The system contains the necessary radiopaque components to conduct the procedure and the system should be introduced through a minimum 7 Fr guide sheath. The Delivery Catheter is flexible and designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip. The Basket Wire is comprised of two distal self-expanding baskets mounted on a core wire for capturing thrombus. The distal capture baskets have integral radiopaque markers mounted on the struts of the basket for basket visibility under fluoroscopy. The Funnel Catheter is used for thrombus collection and retrieval in conjunction with the Basket Wire. The Funnel Catheter is comprised of an inner funnel catheter and an outer delivery catheter. The two catheters work together to allow unsheathing and sheathing of the slider button on the integrated handle.
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    K Number
    K231022
    Device Name
    Pounce™ Thrombectomy System
    Manufacturer
    Surmodics Inc.
    Date Cleared
    2023-06-12

    (63 days)

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

    Surmodics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm in diameter.
    Device Description
    The Surmodics Pounce™ Thrombectomy System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the peripheral arterial vasculature. The system is comprised of three separate components: a Delivery Catheter, a Basket Wire, the Funnel Catheter, and cleaning tool accessories. The system contains radiopaque components to conduct the procedure and is intended to be introduced through appropriately sized guide sheath. The Delivery Catheter is flexible and designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip. The Basket Wire is comprised of two distal self-expanding baskets mounted a core wire for capturing thrombus. The distal capture baskets have integral radiopaque markers mounted on the struts of the basket for basket visibility under fluoroscopy. The Funnel Catheter is used for thrombus collection and retrieval in conjunction with the Basket Wire. The Funnel Catheter is comprised of an inner funnel catheter and an outer delivery catheter. The two catheters work together to allow unsheathing of the funnel using the slider button on the integrated handle.
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    K Number
    K221886
    Device Name
    Sublime Microcatheter
    Manufacturer
    Surmodics Inc.
    Date Cleared
    2022-10-14

    (107 days)

    Product Code
    DQY, KRA
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surmodics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sublime™ Microcatheter is intended to access the peripheral vasculature in order to facilitate the placement and/or the exchange of guidewires. The Sublime Microcatheter is also intended to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
    Device Description
    The Sublime Microcatheter is a sterile, single-use, disposable intravascular catheter with an atraumatic distal tip and a proximal hub with a luer fitting. The Sublime Microcatheter is a single lumen support catheter, compatible with 014", 018", and 035" guide wire platforms and a 4F guide catheter. It has a working length of up to 200 cm, and both straight and angled tip configurations. The catheter has a stainless-steel braid supported construction with hydrophilic coating. The distal end of the catheter includes a radiopaque markerband to facilitate visualization under fluoroscopy.
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    K Number
    K220501
    Device Name
    Pounce Thrombectomy System
    Manufacturer
    Surmodics Inc.
    Date Cleared
    2022-03-23

    (29 days)

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

    Surmodics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pounce™ Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
    Device Description
    The Surmodics Pounce™ Thrombectomy System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the peripheral arterial vasculature. The system is comprised of three separate components: a Delivery Catheter, a Basket Wire with a preloaded loading tool, and the Funnel Catheter. The system contains radiopaque components to conduct the procedure and is intended to be introduced through a minimum 7Fr guide sheath. The Delivery Catheter is a flexible 5Fr catheter designed to deliver the Basket Wire to the location of the thrombus. Incorporated in the catheter is a radiopaque marker band located at the distal tip. The Basket Wire is comprised of two distal self-expanding baskets mounted a core wire for capturing thrombus. The distal capture baskets have integral radiopaque markers mounted on the struts of the basket for basket visibility under fluoroscopy. The Funnel Catheter is used for thrombus collection and retrieval in conjunction with the Basket Wire. The Funnel Catheter is comprised of an inner funnel catheter and an outer delivery catheter. The two catheters work together to allow unsheathing and sheathing of the funnel using the slider button on the integrated handle.
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