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510(k) Data Aggregation

    K Number
    K001901
    Manufacturer
    Date Cleared
    2000-09-19

    (89 days)

    Product Code
    Regulation Number
    880.5970
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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