BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Aventus Clot Management System

    K Number: K240426 · Decision May 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    8
    Review Days
    91

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Aventus Clot Management System
    K Number
    K240426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inquis Medical
    Date Received
    February 13, 2024
    Decision Date
    May 14, 2024
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAC Apparatus, Autotransfusion

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CAC), ordered by most recent decision date.

    XTRA Collection sets; XTRA Sequestration set X

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    XTRA Autotransfusion System (with XTRA Bowl sets)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FlowSaver Blood Return System (80-101)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FlowSaver Blood Return System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Inquis Medical

    K Number Device Name
    K260091 Aventus Introducer Sheath
    K253925 Aventus Thrombectomy System
    K251189 Aventus Thrombectomy System
    K250668 Aventus Thrombectomy System (IM-2100)
    K250202 Aventus Thrombectomy System
    K240117 Aventus Thrombectomy System (IM-2001/IM-0002)
    K232730 Aventus Thrombectomy System