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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: DYG FDA class 2

    Catheter, Flow Directed

    Cardiovascular

    View full classification →

    The Flow-Directed Catheter is a cardiovascular device designed to be carried by blood flow to the right heart and pulmonary artery, commonly used to measure pulmonary arterial pressures and cardiac output in hemodynamic monitoring. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYG and the applicable regulation is 21 CFR 870.1240, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
    Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
    Swan-Ganz catheter
    Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
    Swang-Ganz IQ pulmonary artery catheter
    Swan-Ganz Catheters
    Swan Ganz Catheters
    PERCUPRO MESSENGER BALLOON CATHETER
    OCCLUSION BALLOON CATHETER, MODEL VENOS
    ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
    ATTAIN 6215 VENOGRAM BALLOON CATHETER
    Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
    SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
    CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
    HARMAC THERMODILUTION CATHETER
    VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
    FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
    SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
    SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
    FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED
    SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
    FLOW DIRECTED THERMODILUTION BALLOON CATHETER
    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
    SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
    CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR
    FLOW DIRECTED THERMODILUTION BALLOON CATHETER
    INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER
    INTHERM TEMPORARY OCCLUSION CATHETER
    STEALTH DILATION CATHETER SYSTEM/MODIFICATION
    TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
    SOFT-WEDGE(TM) SYRINGE
    SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
    SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
    CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
    BARD CATH LAB THERMODILUTION CATHETER
    MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
    SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
    MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
    DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.
    DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
    CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
    BARD-PARKER OCCLUSION BALLOON CATHETER
    BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
    MEDTRONIC MODEL 6404
    THERMAL DILUTION CATHETER
    FLOW-DIRECTED THERMODILUTION CATH
    NOVA BALLOON THERMODILUTION INFUSION
    NOVA BALLOON THERMODILUTION CATH.
    WEDGE PRESSURE CATHETER FLOW DIRECTED
    POLYURETHANE THERMAL DILUTION CATHET

    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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