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

    STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE

    K Number: K001961 · Decision Jan 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    13
    Review Days
    212

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    Basic Information

    Device Name
    STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE
    K Number
    K001961
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stoeckert Instrumente
    Date Received
    June 27, 2000
    Decision Date
    January 25, 2001
    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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    K971520 S3 CYCLIC RPM CONTROL
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