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510(k) Data Aggregation

    K Number
    K253646

    Validate with FDA (Live)

    Date Cleared
    2026-02-22

    (94 days)

    Product Code
    Regulation Number
    876.1500
    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
    K251692

    Validate with FDA (Live)

    Date Cleared
    2026-02-21

    (264 days)

    Product Code
    Regulation Number
    876.4300
    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
    K251890

    Validate with FDA (Live)

    Date Cleared
    2026-02-20

    (245 days)

    Product Code
    Regulation Number
    876.4620
    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
    K250550

    Validate with FDA (Live)

    Date Cleared
    2026-02-17

    (357 days)

    Product Code
    Regulation Number
    876.1500
    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
    K252400

    Validate with FDA (Live)

    Date Cleared
    2026-02-13

    (197 days)

    Product Code
    Regulation Number
    876.1500
    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
    K251760

    Validate with FDA (Live)

    Date Cleared
    2026-02-12

    (248 days)

    Product Code
    Regulation Number
    876.5320
    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
    K252459

    Validate with FDA (Live)

    Date Cleared
    2026-02-10

    (189 days)

    Product Code
    Regulation Number
    876.5860
    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
    K253568

    Validate with FDA (Live)

    Date Cleared
    2026-02-06

    (81 days)

    Product Code
    Regulation Number
    876.1500
    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
    K252457

    Validate with FDA (Live)

    Date Cleared
    2026-01-30

    (178 days)

    Product Code
    Regulation Number
    876.1500
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is intended to be used in combination with compatible colonoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

    This product needs to be cut and connected to the endoscope tip of 9mm to 14mm, and medical tape needs to be prepared in advance to fix it into a cylindrical shape.

    Device Description

    This product is intended to be attached to an endoscope.

    The Disposable Distal End Tape Hood is installed at the tip of the endoscope to assist the endoscope in a clearer observation. It can push away the mucosa and keep a certain distance between the lens and the mucosa, thus maintaining the field of view.

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    K Number
    K254305

    Validate with FDA (Live)

    Date Cleared
    2026-01-30

    (30 days)

    Product Code
    Regulation Number
    876.5880
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Paragonix BAROguard is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.

    The intended organ storage time for BAROguard is up to 8 hours.

    Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

    Note: Partial lungs can be transported via BAROguard by packaging lungs per institutional protocol and UNOS guidelines.

    Device Description

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