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510(k) Data Aggregation

    K Number
    K251070

    Validate with FDA (Live)

    Device Name
    Akura Thrombectomy System
    Manufacturer
    Akura Medical
    Date Cleared
    2025-11-25

    (232 days)

    Product Code
    QEW
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K183403,K192981
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Akura Thrombectomy Catheter System:
    As part of the Akura Thrombectomy System, the Akura Thrombectomy Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

    The Akura Thrombectomy Accessory Kit:
    As part of the Akura Thrombectomy System, the Akura Accessory Kit is indicated to connect the Akura Thrombectomy Catheter to the Akura Thrombectomy Console.

    The Akura Thrombectomy Console:
    The Akura Thrombectomy Console is indicated as a vacuum source for the Akura Thrombectomy System.

    Device Description

    The subject Akura Thrombectomy System is designed to remove thrombus from the vasculature. The System is used by interventionalists trained in percutaneous endovascular thrombectomy procedures. The subject Akura Thrombectomy System is comprised of several devices.

    • Akura Thrombectomy Catheter System
      • Akura Thrombectomy Catheter
      • Akura Thrombectomy Sheath
      • Akura Thrombectomy Dilator
    • Akura Thrombectomy Console
    • Akura Accessory Kit
      • Saline Pump
      • Irrigation Tubing
      • Aspiration Canister Assembly

    During use, the Akura Thrombectomy Catheter System and Akura Thrombectomy Accessory Kit are connected to the Akura Thrombectomy Console that is placed outside the sterile field. The Akura Thrombectomy System is introduced through percutaneous access using a commercially available 16F vascular introducer sheath and a 0.035 in exchange length guidewire. The Akura Thrombectomy Catheter System is delivered to the target treatment site under fluoroscopic guidance. The Akura Thrombectomy Dilator is removed from the Akura Thrombectomy Sheath. The Akura Thrombectomy Catheter is inserted through the Akura Thrombectomy Sheath, and the Akura Thrombectomy Catheter funnel is deployed. Thrombus is removed by fragmentation using internal saline jets and aspiration. After the procedure, the Akura Thrombectomy Catheter System is removed from the vasculature and disposed of using standard hospital practices. The Akura Thrombectomy Console is cleaned and stored in accordance with the Akura Thrombectomy System User Manual.

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