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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: DSY FDA class 2

    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

    Cardiovascular

    View full classification →

    The Vascular Graft Prosthesis of 6mm and Greater Diameter is an implantable cardiovascular device used to replace or bypass diseased or damaged large blood vessels, maintaining blood flow through the reconstructed vascular segment. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSY and it is regulated under 21 CFR 870.3450 within the Cardiovascular medical specialty. This device is flagged as an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Gelweave™ Vascular Prostheses
    Gelsoft™ Plus Vascular Prostheses
    Advanta VXT Vascular Graft, Flixene Vascular Graft
    GORE® PROPATEN® Vascular Graft
    exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
    GORE® PROPATEN® Vascular Graft
    GORE® ACUSEAL Vascular Graft
    GORE® ACUSEAL Vascular Graft
    HeRO Graft
    exGraft, exGraft Carbon
    HeRO Graft, HeRO Adapter
    Vascutek Gelsoft Plus ERS Vascular Graft
    exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
    exGraft, exGraft Carbon
    exGraft, exGraft Carbon ePTFE Vascular Grafts
    HeRO Graft
    Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
    Gelweave Vascular Grafts
    FUSION Vascular Graft
    Spiral Flow Peripheral Vascular Graft
    SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
    SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
    FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
    GORE ACUSEAL VASCULAR GRAFT
    FLIXENE IFG VASCULAR GRAFT
    HERO GRAFT
    LIFESPAN EPTFE VASCULAR GRAFT
    ATRIUM FLIXENE IFG VASCULAR GRAFT
    HERO GRAFT
    HERO GRAFT
    EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
    CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
    ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
    SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
    GORE HYBRID VASCULAR GRAFT
    GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
    MAXIFLO, TAPERFLO
    VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
    HERO VASCULAR ACCESS DEVICE
    VASCUTEK BRANCHED GELWEAVE
    EPTFE SLFTM SPIRAL VASCULAR GRAFT
    HERO VASCULAR ACCESS DEVICE
    PTFE FLIXENE GRADUATED WALL GRAFT
    GORE PROPATEN VASCULAR GRAFT
    VASORING* VRC VASCULAR RING CONNECTOR
    SWIRLGRAFT VASCULAR ACCESS GRAFT
    ATRIUM FLIXENE GRAFT
    VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
    EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
    SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS

    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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