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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: DWF FDA class 2

    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

    Cardiovascular

    View full classification →

    The Vascular Catheter, Cannula, and Tubing for Cardiopulmonary Bypass is a cardiovascular device set used to establish vascular access and connect the patient to the extracorporeal bypass circuit, facilitating venous drainage and arterial return during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWF and it is regulated under 21 CFR 870.4210 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    RAP Femoral Venous Cannulae
    Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
    MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula
    Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
    R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
    EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);
    DLP Silicone Coronary Artery Ostial Cannulae
    DLP™ Silicone Coronary Artery Ostial Cannulae
    Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS
    Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
    Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
    AngioVac F18 85
    Bio-Medicus Life Support Catheter and Introducer
    Quantum Perfusion Arterial Cannula Graft
    Michler-Kapp Cardiovascular Vent Catheter
    R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
    QuickDraw Venous Cannula
    Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
    AngioVac C20, AngioVac C180
    CardioGard Emboli Protection Cannula
    Bio-Medicus Insertion Kit
    PureFlex Arterial Cannulae
    DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
    ProtekDuo Mini Veno-Venous Cannula Set
    Bio-Medicus Adult Cannulae Kit
    Bio-Medicus Adult Cannulae and Introducer
    Tubing Pack
    Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr
    Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
    Tubing Pack
    Ostial Sprit Cannulae
    Protek Solo 24 Fr Venous Cannula Set
    PROTEK Duo 31 Fr. Veno-Venous Cannula Set
    Medtronic Bio-Medicus Adult Cannula Kit
    Thoratec CentriMag Drainage (Venous) Cannula Kit
    Thoratec CentriMag Return (Arterial) Cannula Kit
    Uncoated Tubing and Connector Components
    Terumo Circuit Tubing
    MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
    Bio-Medicus Pediatric Cannula and Introducers
    EOPA 3D Arterial Cannula
    CARDIOGARD EMBOLI PROTECTION CANNULA
    DLP Vein Graft Cannula
    ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
    Bio-Medicus Adult Cannulae and Introducer
    AngioVac Cannula
    DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE
    TANDEMHEART VENO-VENOUS CANNULA
    CARPENTIER BI-CAVAL FEMORAL CANNULA
    MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE

    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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