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

    STOCKERTIR PURGE CONTROL (APC) SYSTEM

    K Number: K041558 · Decision Jul 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    16
    Applicant Total
    9
    Review Days
    22

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    Basic Information

    Device Name
    STOCKERTIR PURGE CONTROL (APC) SYSTEM
    K Number
    K041558
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stockert Instrumente GmbH
    Date Received
    June 10, 2004
    Decision Date
    July 2, 2004
    Product Code
    DTW
    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
    DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass

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    Other Clearances by Stockert Instrumente GmbH

    K Number Device Name
    K042374 STOCKERT SCP RHYTHM
    K032213 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
    K023622 STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
    K022280 STOCKERT CORONARY PERFUSION CANNULAE
    K022321 STOCKERT V172-28 VENOUS FEMORAL CANNULA
    K020571 STOCKERT CENTRIFUGAL PUMP CONSOLE
    K011838 CENTRIFUGAL PUMP
    K011088 SIII ALARM AMPLIFIER