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510(k) Data Aggregation

    K Number
    K251185
    Manufacturer
    Date Cleared
    2025-10-22

    (189 days)

    Product Code
    Regulation Number
    870.5150
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K212632

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Recana Thrombectomy Catheter System is indicated for:

    • The non-surgical removal of thrombi and emboli from veins.
    • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vein.

    The Recana Thrombectomy Catheter System is indicated for use in peripheral venous vasculature.

    Device Description

    The Recana Thrombectomy Catheter System is designed to remove thrombus and emboli from native vessels or stented veins. The system is comprised of the debulking catheter, collection basket(s) with delivery sheaths, and a family of sheaths. Together, the Recana Thrombectomy Catheter System functions to capture and remove obstructive / occlusive thrombus from the venous vasculature.

    The debulking catheter utilizes an adjustable diameter stainless steel coring element to remove thrombus from the venous vasculature. Handle controls enable expansion and collapse of the coring element to achieve the desired working diameter. The debulking catheter is 0.035" guidewire and 0.060" basket shaft compatible and provides a working length of 80cm.

    18mm and 30mm Collection basket(s) are self-expanding nitinol wire-form and braided structures designed to ensure capture and removal of thrombi and emboli. The basket shaft has a 0.035" guidewire compatible lumen for over the wire delivery through a 9Fr Delivery Sheath with a working length of 95cm.

    Sheaths for introduction of the debulking catheter and collection baskets into the vasculature and for the recapture and removal of thrombi and emboli via the collection basket(s) are offered in four (4) size configurations (13Fr x 30cm, 13Fr x 90cm, 16Fr x 30cm, and 16Fr x 90cm) providing optionality based on access vessel size and location.

    AI/ML Overview

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