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    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: QEW FDA class 2

    Peripheral Mechanical Thrombectomy With Aspiration

    Cardiovascular

    View full classification →

    The Peripheral Mechanical Thrombectomy With Aspiration device is a cardiovascular device designed to mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration, used in the treatment of peripheral vascular occlusions. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 870.5150 in the Cardiovascular specialty. The product code is QEW. It is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Excipio LV Prime Thrombectomy Device
    Aventus Thrombectomy System
    Liberant Thrombectomy System
    Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System
    InThrill™ Thrombectomy System
    Aventus Thrombectomy System (IM-2100)
    FlowTriever2 Catheter
    Aventus Thrombectomy System
    Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath
    ClotTriever XL Catheter (41-102)
    Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
    Pounce XL Thrombectomy System (PTS-1011-7F135)
    Indigo® Aspiration System – Aspiration Catheter 6X
    ICHOR 7F Embolectomy System (ICH-7F)
    Indigo® Lightning Flash Aspiration System – Select +™ Catheter
    SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)
    ICE Aspiration System
    Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister
    Aventus Thrombectomy System (IM-2001/IM-0002)
    VenaCore Thrombectomy Catheter (46-101)
    Indigo® Aspiration System - Lightning® Flash
    Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister
    ClotTriever Sheath
    Aventus Thrombectomy System
    ICHOR 14F Embolectomy System
    Triever20 Curve (21-201)
    Pounce™ Thrombectomy System
    Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)
    Excipio SV Aspiration Catheter and Tubing
    Artix BG
    ClotTriever XL Catheter
    ClotTriever BOLD Catheter
    Aspirex™ Thrombectomy System
    ROVO Mechanical Thrombectomy Device
    Triever16 Curve
    InThrill Thrombectomy System
    RevCore™ Thrombectomy Catheter.
    Protrieve Sheath
    Artix AX
    Symphony Thrombectomy System
    Excipio LV Thrombectomy Device
    Cobra Catheter System
    Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
    ClotTriever Thrombectomy System
    Artix BG
    Indigo Aspiration System - Lightning Flash
    WOLF Thrombectomy™ SmartClaw Catheter
    INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
    Mini-ClotTriever Thrombectomy System
    Protrieve Sheath

    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.

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