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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: DXT FDA class 2

    Injector And Syringe, Angiographic

    Cardiovascular

    View full classification →

    The Angiographic Injector and Syringe is a cardiovascular device used to deliver contrast media rapidly and precisely into blood vessels during angiographic imaging procedures, enabling visualization of vascular anatomy. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DXT and the applicable regulation is 21 CFR 870.1650, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr
    ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
    VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)
    High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
    Extension tube
    MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
    High Pressure Tubing
    Angiography Injector
    Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)
    Single-use Sterile High-pressure Angiographic Syringes and Accessories
    Disposable High-pressure Extension Lines
    High Pressure Tubing
    Sterile High-pressure Angiographic Syringes for Single-use
    ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
    Sterile High-pressure Angiographic Syringes for single-use
    Sterile High-pressure Angiographic Syringes for Single-use
    MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
    MEDRAD Mark 7 Arterion Injection System
    DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System
    ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
    DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System
    MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
    MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
    DyeVert PLUS EZ Contrast Reduction System
    Sterile High-pressure Angiographic Syringes for Single-use
    MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
    Sterile Disposable Syringes
    ACISTCVi® Contrast Delivery System
    PRESS DUO elite, PRESS DUO elite AG
    Disposable High Pressure Syringe
    CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
    Smart Syringe
    Merit Coronary Control Syringe
    DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
    DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
    Ecomed Disposable Angiographic Syringes
    Disposable High Pressure Injector Syringe
    Sunmed Control Syringes
    MR Syringe Dual Pack for Solaris Injectors
    DyeVert NG Contrast Modulation System
    DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
    DeRoyal Angiography Kits
    DyeVert Contrast Modulation System
    Sterile High-pressure Angiographic Syringes for Single-use
    330psi Extension Y-Line with Dual Check Valve
    AVERT Contrast Modulation System
    Dyevert Contrast Modulation System
    AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System
    MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit
    125mL CT Syringe

    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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