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510(k) Data Aggregation

    K Number
    K982385
    Device Name
    POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    1999-02-01

    (207 days)

    Product Code
    KRJ,NOV
    Regulation Number
    870.4280
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • . THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS.
    • THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS . BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.
    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for a disposable cardiopulmonary pre-bypass filter, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this document.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary regulatory pathway for this type of medical device. There is no mention of an AI/ML component or study involving such.

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