BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PCTE MICROPOROUS MEMBRANE FILTER

    K Number: K870196 · Decision May 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    112

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PCTE MICROPOROUS MEMBRANE FILTER
    K Number
    K870196
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Poretics Corp.
    Date Received
    January 20, 1987
    Decision Date
    May 12, 1987
    Product Code
    KET
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KET Filters, Cell Collection, Tissue Processing

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KET), ordered by most recent decision date.

    DISPOSABLE STERILE SYRINGE FILTERS

    FDA 510(k)
    FDA Class 1 ·Pathology

    CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON

    FDA 510(k)
    FDA Class 1 ·Pathology

    DISPOSABLE SYRINGE FILTERS

    FDA 510(k)
    FDA Class 1 ·Pathology

    STERILIZATION PROCESS/OUTERWRAP

    FDA 510(k)
    FDA Class 1 ·Pathology
    View all