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510(k) Data Aggregation

    K Number
    K970648
    Device Name
    PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)
    Manufacturer
    RENAL SYSTEMS, INC.
    Date Cleared
    1998-01-05

    (319 days)

    Product Code
    MSF
    Regulation Number
    876.5860
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Primus® Hollow Fiber Dialyzer is indicated for hemodialysis of patients with acute or chronic renal insufficiency. The Primus Dialyzer is intended for reuse.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Primus® Hollow Fiber Dialyzer," intended for hemodialysis and reuse. It does not contain information regarding detailed acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment methods for an AI/ML powered medical device. The document is a regulatory approval, not a technical performance report.

    Therefore, I cannot provide the requested information based on the provided text.

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