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

    VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)

    K Number: K250013 · Decision Mar 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    85
    Applicant Total
    1
    Review Days
    81

    Basic Information

    Device Name
    VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
    K Number
    K250013
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Control Medical Technology, Inc. / dba VentiV Scientific
    Date Received
    January 2, 2025
    Decision Date
    March 24, 2025
    Product Code
    QEZ
    Advisory Committee
    Cardiovascular
    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
    QEZ Aspiration Thrombectomy Catheter

    Similar 510(k) Clearances

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

    JETi Hydrodynamic Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AlphaVac MMA F1885 System (H787253020)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JETi™Hydrodynamic Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JETi AIO Peripheral Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASAP Aspiration Catheter, ASAPLP Aspiration Catheter

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