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510(k) Data Aggregation

    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
    K251900

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    Device Name
    MY01 Continuous Compartmental Pressure Monitor
    Manufacturer
    MY01, Inc.
    Date Cleared
    2026-01-16

    (210 days)

    Product Code
    LXC
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    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
    K251744

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    Device Name
    Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter
    Manufacturer
    Medtronic
    Date Cleared
    2026-01-16

    (224 days)

    Product Code
    DTM
    Regulation Number
    870.4260
    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
    K251831

    Validate with FDA (Live)

    Device Name
    Bio-Medicus Life Support Catheter and Introducer
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2026-01-15

    (216 days)

    Product Code
    QHW
    Regulation Number
    870.4100
    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
    K253171

    Validate with FDA (Live)

    Device Name
    Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
    Manufacturer
    Maxx Orthopedics, Inc.
    Date Cleared
    2026-01-15

    (111 days)

    Product Code
    LZO,MEH,OQI
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    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
    K253470

    Validate with FDA (Live)

    Device Name
    MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
    Manufacturer
    Medtronic Minimed, Inc.
    Date Cleared
    2026-01-15

    (97 days)

    Product Code
    QFG
    Regulation Number
    880.5730
    Type
    Traditional
    Panel
    Clinical Chemistry
    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
    K253511

    Validate with FDA (Live)

    Device Name
    Concerto Versa™ Detachable Coil
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2026-01-14

    (70 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    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
    K252958

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    Device Name
    METICULY Patient-specific titanium mesh implant
    Manufacturer
    Meticuly Co., Ltd.
    Date Cleared
    2026-01-14

    (120 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    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
    K253585

    Validate with FDA (Live)

    Device Name
    SmartGuard technology; Predictive Low Glucose technology
    Manufacturer
    Medtronic Minimed, Inc.
    Date Cleared
    2026-01-14

    (58 days)

    Product Code
    QJI
    Regulation Number
    862.1356
    Type
    Traditional
    Panel
    Clinical Chemistry
    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
    K251214

    Validate with FDA (Live)

    Device Name
    BEAR® (Bridge-Enhanced ACL Restoration) Implant
    Manufacturer
    Miach Orthopaedics, Inc.
    Date Cleared
    2026-01-13

    (270 days)

    Product Code
    QNI
    Regulation Number
    888.3044
    Type
    Traditional
    Panel
    Orthopedic
    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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