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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: DRF FDA class 2

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    Cardiovascular

    View full classification →

    The Electrode Recording Catheter (or Electrode Recording Probe) is a cardiovascular electrophysiology device used intracardiac or intravascularly to record electrical signals from within the heart or blood vessels, aiding in the diagnosis of arrhythmias and other cardiac conditions. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRF and it is regulated under 21 CFR 870.1220 within the Cardiovascular medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VIKING™ Fixed Curve Diagnostic Catheter
    EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter
    Nordica PV Cryo Mapping Catheter
    Cosine-10TM Diagnostic Catheter
    Polaris X™ Unidirectional Steerable Diagnostic Catheter
    BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
    Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
    EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
    IntellaMap Orion High Resolution Mapping Catheter
    RithmID-SD Steerable Diagnostic Electrophysiology Catheter
    Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
    LASSOSTAR NAV Circular Mapping Catheter
    ViaCath, AcQRate Dx Steerable Catheter
    Polaris X Unidirectional Steerable Diagnostic Catheter
    Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
    MultiCath, AcQRate Dx Fixed Curve Catheter
    Reprocessed Inquiry Steerable Diagnostic EP Catheter
    LassoStar Circular Mapping Catheter
    Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
    IntellaMap Orion High Resolution Mapping Catheter
    Advisor VL Circular Mapping Catheter, Sensor Enabled
    Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
    Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
    Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
    Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
    Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
    Reprocessed Supreme Diagnostic Electrophysiology Catheter
    Reprocessed Inquiry Steerable Diagnostic EP Catheter
    Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
    Reprocessed Supreme Diagnostic Electrophysiology Catheters
    Achieve Advance Mapping Catheter
    EasyMap MAP Catheter
    Achieve ST Mapping Catheter, Catheter Connecting Cable
    Map-it Diagnostic Mapping Catheters
    St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter
    St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter
    IntellaMap Orion High Resolution Mapping Catheter
    RITHM ID ELECTROPHYSIOLOGY CATHETER
    LASSO NAV DUO LOOP CATHETER
    RHYTHMIA MAPPING CATHETER
    RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
    LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
    WEBSTER DUO-DECAPOLAR CATHETER
    ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
    LIVEWIRE ELECTOPHYSIOLOGY CATHETER
    ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
    INQUIRY AFOCUSII DIAGNOSTIC CATHETER
    WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
    LASSO NAV CATHETER
    CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER

    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
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