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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: DYB FDA class 2

    Introducer, Catheter

    Cardiovascular

    View full classification →

    The Catheter Introducer is a cardiovascular device used to facilitate the insertion and placement of catheters and other instruments into blood vessels, providing a stable access sheath during vascular procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DYB and the applicable regulation is 21 CFR 870.1340, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AuST Steerable Sheath
    Prelude Wave Hydrophilic Sheath Introducer
    PeriCross™ Epicardial Access Kit
    Edwards eSheath Optima introducer set
    iSLEEVE Introducer Set
    ViaOne Epicardial Access System
    Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca
    Agilis NxT Steerable Introducer Dual-Reach
    Element Vascular Access System
    Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
    SonoStik Guide Wire Introducer
    AuST Steerable Sheath
    Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
    SafeCross Vascular Introducer System (4001)
    Morph DNA Steerable Introducer Sheath
    Introducer Sheath Kits
    Catapult Guide Sheath
    Abiomed 14Fr Low Profile Introducer Kit
    TLAB® Transvenous Liver Biopsy System (TF-18C)
    Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
    AuST Steerable Sheath
    Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
    NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
    EPi-Ease Epicardial Access Device (EAS)
    CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer
    SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
    FlexCath Cross Transseptal Solution
    Intri24 Introducer Sheath (52-101)
    10F Sheath and Dilator Set
    14F iSLEEVE Introducer Set
    Talon Transseptal Sheath
    Thinline Sheath Introducer
    Pounce™ Sheath
    CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
    Kodiak™ Dual Port Coaxial Introducer Kit
    RAIN Sheath™ Tibial Pedal Introducer
    Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
    Introducer Sheath Kits
    14F iSLEEVE™ Introducer Set
    Low Profile Companion Sheath
    Multiflex Steerable Sheath
    Abiomed 14Fr Low Profile Introducer Set
    INT Introducer Set
    Catapult Guide Sheath
    Epicardial Access System
    Liverty™ TIPS Access Set
    VersaCross Connect Transseptal Dilator
    EXTesia Introducer Sheath Set
    Intri24 Sheath
    Dib UltraNav Transseptal Catheter System

    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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