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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: NRY FDA class 2

    Catheter, Thrombus Retriever

    Cardiovascular

    View full classification →

    The Thrombus Retriever Catheter is a cardiovascular device intended to restore blood flow by removing thrombus or clots in patients experiencing ischemic stroke, representing a distinct claim from general-purpose catheters placed in peripheral, coronary, or neurovascular anatomies. It is used in acute intervention to recanalize occluded cerebral vessels. This is an FDA Class 2 device regulated under 21 CFR 870.1250 in the Cardiovascular specialty and reviewed by the Neurology panel, with product code NRY, requiring 510(k) clearance. It is not an implant and does not provide life-sustaining support.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Penumbra System (Thunderbolt Aspiration Tubing)
    Zenith Aspiration Catheter; Disposable Aspiration Tubing Set
    Lynx Aspiration Catheter System
    Millipede System
    Tigertriever 25 Revascularization Device
    Esperance pHLO Aspiration System
    NeVasc Aspiration System
    Zoom System (Zoom 4S Catheter)
    Tigertriever 17 Ultra Revascularization Device
    EMBOTRAP III Revascularization Device
    Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set
    CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
    Raptor Aspiration Catheter; Balt Aspiration Tubing Set
    Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
    Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
    APRO 45 Catheter and Alembic Aspiration Tubing
    APRO 55 Swift Catheter and Alembic Aspiration Tubing
    Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    APRO 70 Swift Catheter and Alembic Aspiration Tubing
    Penumbra System (Reperfusion Catheter RED 72)
    Zoom System
    Riptide Aspiration System
    CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
    Esperance 3+ Aspiration Catheter System
    Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
    Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
    APRO 55 Catheter and Alembic Aspiration Tubing
    Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
    Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    Socrates Aspiration System
    072 Aspiration System
    Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
    Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
    APRO 70 Catheter and Alembic Aspiration Tubing
    CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
    APRO 70 Catheter and Alembic Aspiration Tubing
    Penumbra System (Reperfusion Catheter RED 43)
    Tigertriever 13 Revascularization Device
    ERIC Retrieval Device
    Esperance Aspiration Catheter System
    EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
    Penumbra System (Reperfusion Catheter RED 72)
    EMBOTRAP III Revascularization Device
    Penumbra System (RED 68 Reperfusion Catheter)
    ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
    Penumbra System (Reperfusion Catheter RED 62)
    ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
    Tigertriever and Tigertriever 17 Revascularization Devce
    ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

    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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