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

    24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524

    K Number: K012143 · Decision Oct 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    40
    Applicant Total
    7
    Review Days
    106

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    Basic Information

    Device Name
    24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
    K Number
    K012143
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Cardiac Surgical Products
    Date Received
    July 10, 2001
    Decision Date
    October 24, 2001
    Product Code
    DRA
    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
    DRA Catheter, Steerable

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    Other Clearances by Medtronic Cardiac Surgical Products

    K Number Device Name
    K022272 MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
    K013013 MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
    K010737 SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
    K000776 MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
    K994171 MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
    K000274 EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE