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510(k) Data Aggregation

    K Number
    K243549
    Device Name
    JETi Hydrodynamic Thrombectomy System
    Manufacturer
    Abbott Medical
    Date Cleared
    2025-04-04

    (140 days)

    Product Code
    QEZ,FOX,KDQ
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K232458,K202218
    Why did this record match?
    Reference Devices :

    K232458

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

    The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

    Device Description

    The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study, structured as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Criterion TypeAcceptance CriteriaReported Device Performance
    Primary EffectivenessAt least 75% reduction in modified Marder Score from pre-JETi venogram to final venogram (per core laboratory assessment), with a one-sided 97.5% lower confidence limit comparing to a performance goal of 64%.Achieved in 84.5% (93/110) limbs, with a one-sided 97.5% lower confidence limit of 76.4%, which compares favorably to the performance goal of 64% (p value
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