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

    STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35

    K Number: K023622 · Decision Nov 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    9
    Review Days
    23

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    Basic Information

    Device Name
    STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
    K Number
    K023622
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stockert Instrumente GmbH
    Date Received
    October 29, 2002
    Decision Date
    November 21, 2002
    Product Code
    DWF
    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
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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    Other Clearances by Stockert Instrumente GmbH

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    K022280 STOCKERT CORONARY PERFUSION CANNULAE
    K022321 STOCKERT V172-28 VENOUS FEMORAL CANNULA
    K020571 STOCKERT CENTRIFUGAL PUMP CONSOLE
    K011838 CENTRIFUGAL PUMP
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