BEUDAMED
    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: QEZ FDA class 2

    Aspiration Thrombectomy Catheter

    Cardiovascular

    View full classification →

    The Aspiration Thrombectomy Catheter is a catheter device used to remove thrombus from the peripheral and/or coronary vasculature through aspiration, restoring blood flow in cases of vascular occlusion. It is classified as FDA Class 2 and is GMP exempt, operating under regulation 870.5150 in the Cardiovascular specialty. The product code is QEZ. It is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    JETi Hydrodynamic Thrombectomy System
    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)
    AlphaVac MMA F1885 System (H787253020)
    JETi™Hydrodynamic Thrombectomy System
    AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
    JETi AIO Peripheral Thrombectomy System
    ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
    Thrombuster II Aspiration Catheter
    AlphaVac Multipurpose Mechanical Aspiration (MMA) System
    JETi AIO Peripheral Thrombectomy System
    Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
    QuickClear Mechanical Thrombectomy System
    JETi Peripheral Thrombectomy System
    Aspiron(TM) Aspiration Catheter
    JETi 88 Peripheral Thrombectomy System
    Octane Mechanical Thrombectomy System
    Octane aspiration system
    ClearLumen II Peripheral Thrombectomy System
    ClearLumen II Peripheral Thrombectomy System
    ClearLumen II Thrombectomy System
    CLEARLUMEN THROMBECTOMY SYSTEM
    ASPIRE RX-LP6 ASPIRATION CATHETER
    Merit ASAPLP Aspiration Catheter
    EXPORT ADVANCE ASPIRATION CATHETER
    REFLOW ASPIRATION CATHETER
    CLEARLUMEN THROMBECTOMY SYSTEM
    XPRESSWAY RX CATHETER (6F LD-VERISON)
    EXPORT XT CATHETER, EXPORT AP CATHETER
    ANGIOJET SOLENT DISTA THROMBECTOMY SET
    ASPIRE MAX ASPIRATION CATHETER
    TERUMO ASPRIATION CATHETER
    ANGIOJET ULTRA DVX THROMBECTOMY SET
    NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
    XL EXTRACTION CATHETER
    ANGIOJET SOLENT OMNI THROMBECTOMY SET
    MERIT EMBOLECTOMY CATHETER MODEL ASAP100
    FETCH 2 ASPIRATION CATHETER MODEL 109400-001
    PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH
    KANEKA PHARMA AMERICA XPRESS-WAY RX
    ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
    HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
    ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
    ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
    PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
    ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
    MODIFICATION TO FETCH ASPIRATION CATHETER
    ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
    QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
    FLEXOR EVAC ASPIRATION CATHETER
    ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump