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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: LDF FDA class 2

    Electrode, Pacemaker, Temporary

    Cardiovascular

    View full classification →

    A temporary pacemaker electrode is a transvenous or epicardial electrode used in the short-term treatment of cardiac arrhythmias, bradycardia, or heart block by delivering electrical pacing stimuli to the myocardium until a permanent pacemaker can be implanted or the underlying condition resolves. It is classified as FDA Class 2, requiring 510(k) premarket clearance, under 21 CFR 870.3680 in the Cardiovascular specialty. The product code is LDF. This device is designated as life sustaining or life supporting due to its critical cardiac function.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Bioptimal Bipolar Pacing Catheter
    Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
    Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,
    Rotatable Connector (5944RL)
    Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
    TME Temporary Myocardial Electrode
    Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
    Temporary Cardiac Pacing Wire
    Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
    Pacel Flow Directed Pacing Catheter
    Tempo Temporary Pacing Lead
    Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
    Pacel Bipolar Pacing Catheters
    Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
    UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING
    TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
    MODEL 6416 TEMPORARY PACING LEAD SYSTEM
    DETECT SURGICAL PACING AND MAPPING TOOL
    TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
    TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
    DISPOSABLE TEMPORARY PACING WIRE
    STEELEX ELECTRODE SET
    WECK CARDIAC PACING WIRES
    MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
    MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
    MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
    MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
    MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
    ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
    ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
    ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3
    ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
    MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
    TEMPORARY CARDIAC PACING WIRE
    INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
    SAFPACE SYSTEM
    HARMAC TEMPORARY PACING CATHETER WITH BALLOON
    HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
    INTRODUCER SHEATH AND DILATOR
    MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
    UNIPOLAR IPG GROUND CABLE, MODEL 5473
    ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
    USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
    RV PACING LEAD
    FLEXON TEMPORARY CARDIAC PACER LEAD
    UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
    MULTIPACE
    UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
    UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
    TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

    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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