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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: DRE FDA class 2

    Dilator, Vessel, For Percutaneous Catheterization

    Cardiovascular

    View full classification →

    The Vessel Dilator for Percutaneous Catheterization is a cardiovascular device used to progressively enlarge a puncture site in a blood vessel, allowing passage of a catheter or introducer sheath during percutaneous access procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRE and it is regulated under 21 CFR 870.1310 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    VersaCross Connect™ Transseptal Dilator
    Micro Ace Gold Advanced Micro Access System
    VersaCross Connect™ Transseptal Dilator
    VersaCross Connect™ Transseptal Dilator
    Micro Ace™ Advanced Micro Access System
    TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
    TightRail Guardian Motorized Dilator Sheath
    Xtractor device
    Endovascular Dilator and Sets
    ExpanSure Large Access Transseptal Dilator
    MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
    Super Sheath
    Sterile Dilator
    S-MAK XL
    ExpanSure Transseptal Dilation System
    Dilator Sets
    MC3 Vascular Access Kit 21030
    Coaxial Dilator Set (Micro-Introducer)
    Medcomp Vessel Dilator
    van Andel Dilatation Catheter
    Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
    VSI StraitSet micro-introducer kit
    Sheath Introducer
    TightRail Sub-C Rotating Dilator Sheath
    MicroTract Access System
    MicroTaper Needle Introducer Set
    TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
    SUPER SHEATH
    Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
    TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
    EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
    TIGHTRAIL MINI
    LEXICONTURE MECHANICAL DILATOR SHEATH SET
    LEXIPLIANT DILATOR SHEATH SET
    NMI COAXIAL MICROINTRODUCER SET
    LAWMAX DILATOR
    PRELUDE SHEATH INTRODUCER
    NMI COAXIAL MICROINTRODUCER SET
    SONIXGPS VASCULAR ACCESS NEEDLE KIT
    ARSTASIS DILATOR ADAPTER
    RETROFLEX DILATOR KIT
    SPECTRANETICS VISISHEATH DILATOR SHEATH
    MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
    AVALON ELITE VASCULAR ACCESS KIT
    HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
    PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
    GALTSTICK INTRODUCER SYSTEM
    ESTECH PERCUTANEOUS INSERTION DILATOR KIT
    PRELUDE SHEATH INTRODUCER
    STARCLOSE HEX-HUB DILATOR

    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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