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510(k) Data Aggregation

    K Number
    K254114

    Validate with FDA (Live)

    Device Name
    Baylis Connector Cable
    Manufacturer
    Baylis Medical Technologies, Inc.
    Date Cleared
    2026-01-18

    (30 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254085

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    Device Name
    CARTO™ 3 EP Navigation System V9.0 with PIU Plus
    Manufacturer
    Biosense Webster, Inc.
    Date Cleared
    2026-01-18

    (31 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253363

    Validate with FDA (Live)

    Device Name
    NeuroSpan Bridge
    Manufacturer
    Auxilium Biotechnologies, Inc.
    Date Cleared
    2026-01-17

    (109 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Type
    Traditional
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251970

    Validate with FDA (Live)

    Device Name
    Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
    Manufacturer
    Medtronic, Ireland
    Date Cleared
    2026-01-17

    (205 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251739

    Validate with FDA (Live)

    Device Name
    da Vinci Surgical System (IS5000)
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2026-01-16

    (224 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251353

    Validate with FDA (Live)

    Device Name
    Eyer 2
    Manufacturer
    Phelcom Technologies
    Date Cleared
    2026-01-16

    (261 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Type
    Traditional
    Panel
    Ophthalmic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251934

    Validate with FDA (Live)

    Device Name
    qXR-Detect
    Manufacturer
    Qure.Ai Technologies
    Date Cleared
    2026-01-16

    (206 days)

    Product Code
    MYN
    Regulation Number
    892.2070
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253556

    Validate with FDA (Live)

    Device Name
    da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2026-01-16

    (63 days)

    Product Code
    NAY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    DEN250005

    Validate with FDA (Live)

    Device Name
    Sana Device
    Manufacturer
    Sana Health
    Date Cleared
    2026-01-16

    (319 days)

    Product Code
    QYN
    Regulation Number
    N/A
    Type
    Direct
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253082

    Validate with FDA (Live)

    Device Name
    LZI Buprenorphine II Enzyme Immunoassay
    Manufacturer
    Lin-Zhi International, Inc.
    Date Cleared
    2026-01-16

    (115 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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