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510(k) Data Aggregation

    K Number
    K971897
    Device Name
    CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
    Manufacturer
    Date Cleared
    1997-10-21

    (152 days)

    Product Code
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDRON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indication for use of the MEDRON CAVH Catheter is for accessing the vascular system for continuous arteriovenous hemofiltration.
    Device Description
    Catheter
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