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510(k) Data Aggregation

    K Number
    K990276
    Device Name
    POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
    Manufacturer
    POROUS MEDIA CORP.
    Date Cleared
    1999-10-01

    (246 days)

    Product Code
    KRJ
    Regulation Number
    870.4280
    Why did this record match?
    Product Code :

    KRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The filter is intended for use only with non-cellular fluid in the extra-. corporeal circuit prior to the initiation of cardiopulmonary bypass. - The DPB30 disposable pre-bypass filter has been designed for single . use and should be discarded once the circuit is primed - The device is intended for adult population only. .
    Device Description
    DPB30 Disposable Pre-bypass Filter
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    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
    Why did this record match?
    Product Code :

    KRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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