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

    INTERSEPT* VENOUS RESERVOIR BAG & HOLDER

    K Number: K803059 · Decision Dec 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    69
    Review Days
    19

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    Basic Information

    Device Name
    INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
    K Number
    K803059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    December 3, 1980
    Decision Date
    December 22, 1980
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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    Other Clearances by Extracorporeal Medical Specialities, Inc.

    K Number Device Name
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    K840262 HANCOCK PERICARDIAL PATCH
    K840146 EXP* 700 PARALLEL PLATE DIALYZER
    K840057 EXP* 500 PARALLEL PLATE DIALYZER
    K831423 THERAPEUTIC EXCHANGE SYSTEM
    K832547 ULTRAFILTRATION CONTROLLER
    K833477 INTERSEPT 40 MICRON FILTER
    K833476 INTERSEPT 40 MICRON FILTER W/TUBING
    K831424 THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
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