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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: MSD FDA class 2

    Catheter, Hemodialysis, Implanted

    Gastroenterology, Urology

    View full classification →

    An Implanted Hemodialysis Catheter is a surgically placed vascular access device used to provide long-term access to the bloodstream for patients undergoing hemodialysis, typically for those with end-stage renal disease. This device is both an implant and classified as life-sustaining, reflecting its critical role in supporting patients dependent on dialysis. It is FDA Class 2, requiring 510(k) clearance, and carries product code MSD under 21 CFR 876.5540 in the Gastroenterology and Urology specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Hemodialysis Catheter
    End Cap
    GlidePath Retro Long-Term Hemodialysis Catheter
    GlidePath 13F Long-Term Hemodialysis Catheter
    Pristine Long-Term Hemodialysis Catheter
    GlidePath 7.5F Long-Term Dialysis Catheter
    Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
    GlidePath 10F Long-Term Dialysis Catheter
    GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
    Pristine Hemodialysis Catheter
    15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
    NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
    NexSite HD, Hemodialysis Step Tip Catheter (60cm)
    Symetrex Long Term Hemodialysis Catheter
    NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
    Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter
    NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)
    SYMETREX LONG TERM HEMODIALYSIS CATHETER
    NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
    VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
    CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
    SPLIT CATH RG
    NMI DIALYSIS CATHETER
    NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (32CM), NEXSITE HD, HEMODIALYSIS CATHETER FOR LONG TERM USE (36CM),
    CASCADE HEMODIALYSIS/APHERESIS CATHETER
    AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
    NEXTSTEP RETROGRADE
    AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
    NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
    PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
    SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
    HEMO-CATH 10F, HEMO-CATH 12.5F
    SPLIT CATH III
    PALINDROME RT CHRONIC CATHETER
    NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
    TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
    CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
    DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
    ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
    ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER
    DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
    DURASPAN HEMODIALYSIS LONG-TERM CATHETER
    DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
    CENTROS CHRONIC HEMODIALYSIS CATHETER SET
    PALINDROME P HEMODIALYSIS CATHETER
    DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)
    DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT
    PROGUIDE CHRONIC DIALYSIS CATHETER
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
    ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT

    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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