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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: MCW FDA class 2

    Catheter, Peripheral, Atherectomy

    Cardiovascular

    View full classification →

    The peripheral atherectomy catheter is a cardiovascular device used to remove atherosclerotic plaque from peripheral arteries through a minimally invasive catheter-based approach, restoring blood flow in patients with peripheral arterial disease. It is classified as FDA Class II under 21 CFR 870.4875 within the Cardiovascular specialty, requiring 510(k) premarket clearance. The product code is MCW and the device is not implanted. Full GMP quality system requirements apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
    Turbo-Elite Laser Atherectomy Catheter
    Rotarex Atherectomy System
    FreedomFlow™ Orbital Circumferential Atherectomy System
    Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
    FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
    Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
    FreedomFlow Orbital Circumferential Atherectomy System
    Auryon Atherectomy System
    Pantheris LV Atherectomy Catheter
    Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
    Auryon Atherectomy Catheters
    ROTAPRO Rotational Atherectomy System
    Auryon Atherectomy System
    Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
    DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
    Revolution Peripheral Atherectomy System
    Pantheris System
    Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
    Rotarex Atherectomy System
    TurboHawk Plus Directional Atherectomy System
    2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
    Auryon Atherectomy System
    DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
    Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
    Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
    Pantheris SV
    Phoenix Atherectomy System
    Phoenix 2.4mm Atherectomy Plus System
    Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
    B-Laser Atherectomy System
    Pantheris System
    ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
    Straub Endovascular System
    Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
    Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
    Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled
    1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
    SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
    Diamondback 360 Peripheral Orbital Atherectomy System
    Spectranetics Turbo-Elite Laser Atherectomy Catheters
    Turbo-Power (2.0mm) Laser Atherectomy Catheters
    Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled
    Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
    HawkOne Directional Atherectomy System
    Pantheris Catheter
    Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
    Turbo-Power Laser Atherectomy Catheter
    Diamondback 360 Peripheral Orbital Atherectomy System
    Pantheris 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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