BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER

    K Number: K982385 · Decision Feb 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    9
    Review Days
    207

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    Basic Information

    Device Name
    POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
    K Number
    K982385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Porous Media Corp.
    Date Received
    July 9, 1998
    Decision Date
    February 1, 1999
    Product Code
    KRJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRJ Filter, Prebypass, Cardiopulmonary Bypass

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    Other Clearances by Porous Media Corp.

    K Number Device Name
    K062091 POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
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    K990276 POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
    K982127 POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
    K965020 POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
    K964979 POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
    K952428 POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER
    K934132 POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER