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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: DTK FDA class 2

    Filter, Intravascular, Cardiovascular

    Cardiovascular

    View full classification →

    The Intravascular Cardiovascular Filter is an implantable cardiovascular device placed within a blood vessel to trap and prevent the passage of emboli, thrombi, or other particulate matter, protecting downstream organs or tissues from occlusion. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTK and it is regulated under 21 CFR 870.3375 within the Cardiovascular medical specialty. This device is flagged as an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Option ELITE Vena Cava Filter System (352506070E 352506100E)
    VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
    ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
    Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
    Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter
    Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
    Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
    Sentry IVC Filter
    Sentry IVC Filter
    Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
    Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
    ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook
    Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
    Sentry IVC filter
    Gianturco-Roehm Bird’s Nest Vena Cava Filter
    Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
    VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
    Option (TM) ELITE Vena Cava Filter 100cm System
    Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular
    Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
    OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
    OPTION ELITE VENA CAVA FILTER SYSTEM
    BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
    CRUX VENA CAVA FILTER SYSTEM
    ALN OPTIONAL VANA CAVA FILTER
    CRUX VENA CAVA FILTER SYSTEM
    COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
    COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
    CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
    MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
    MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
    ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
    OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
    ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
    OPTION VENA CAVA FILTER
    SAFEFLO VENA CAVA FILTER
    GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
    G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
    G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
    COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
    VENA CAVA FILTER
    ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO
    RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J
    GUNTHER TULIP VENA CAVA FILTER
    COOK CELECT VENA CAVA FILTER
    VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
    MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
    BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
    MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
    GUNTHER TULIP VENA CAVA FILTER SET

    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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