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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: QEY FDA class 2

    Mechanical Thrombolysis Catheter

    Cardiovascular

    View full classification →

    The Mechanical Thrombolysis Catheter is a catheter device used to mechanically disrupt thrombus and/or debris in the peripheral vasculature, restoring blood flow without the use of aspiration as the primary removal mechanism. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 870.5150 in the Cardiovascular specialty. The product code is QEY. It is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Versus™ Catheter (VS110-8B)
    BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
    BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
    EKOS+ Endovascular Device
    EkoSonic Endovascular Device, EKOS+ Endovascular Device
    EkoSonic Endovascular Device
    BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)
    UNIFUSE Infusion System with Cooper Wire
    EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
    UNI*FUSE Infusion System with Cooper Wire
    Bashir Plus Endovascular Catheter
    Bashir S-B Endovascular Catheter, Ref. No. 7101
    EkoSonic Endovascular Device
    EkoSonic Endovascular Device with Control Unit 4.0
    Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
    EkoSonic Endovascular System
    Pulse* Spray Infusion System, Uni*Fuse Infusion System
    EkoSonic Endovascular System with Control Unit 4.0
    SpeedLyser Infusion Catheter Kit
    Squirt Fluid Delivery System
    Occlusion Perfusion Catheter
    Occlusion Perfusion Catheter
    EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
    TRELLIS-8 PERIPHERAL INFUSION SYSTEM
    EKOSONIC ENDOVASCULAR SYSTEM
    MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
    SPIRALFUSE PERIPHERAL INFUSION SYSTEM
    EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
    EndoWave Infusion System
    ENDOWAVE INFUSION SYSTEM
    OMNIWAVE ENDOVASCULAR SYSTEM
    ENDOWAVE INFUSION SYSTEM
    EKOS MICRO-INFUSION SYSTEM
    TRELLIS-6 PERIPHERAL INFUSION SYSTEM
    MICRO-INFUSION SYSTEM
    LYSUS INFUSION SYSTEM
    LYSUS INFUSION SYSTEM
    EKOS MICRO-INFUSION SYSTEM
    RESOLUTION ENDOVASCULAR SYSTEM
    LYSUS INFUSION SYSTEM
    LYSUS INFUSION SYSTEM
    EKOS PERIPHERAL INFUSION SYSTEM
    TRELLIS-8 PERIPHERAL INFUSION SYSTEM
    Lysus Infusion System
    Lysus Infusion System
    RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
    LYSUS INFUSION SYSTEM
    INFUSIONCATH
    SPEEDLYSER INFUSION CATHETER KIT
    EKOS PERIPHERAL INFUSION SYSTEM

    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

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