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

    STOCKERT CENTRIFUGAL PUMP CONSOLE

    K Number: K020571 · Decision Sep 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    51
    Applicant Total
    9
    Review Days
    214

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    Basic Information

    Device Name
    STOCKERT CENTRIFUGAL PUMP CONSOLE
    K Number
    K020571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stockert Instrumente GmbH
    Date Received
    February 21, 2002
    Decision Date
    September 23, 2002
    Product Code
    DTQ
    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
    DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

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    Other Clearances by Stockert Instrumente GmbH

    K Number Device Name
    K042374 STOCKERT SCP RHYTHM
    K041558 STOCKERTIR PURGE CONTROL (APC) SYSTEM
    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
    K011838 CENTRIFUGAL PUMP
    K011088 SIII ALARM AMPLIFIER