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510(k) Data Aggregation

    K Number
    K250013
    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)
    Manufacturer
    Control Medical Technology, Inc. / dba VentiV Scientific
    Date Cleared
    2025-03-24

    (81 days)

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

    Control Medical Technology, Inc. / dba VentiV Scientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
    Device Description
    The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.
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