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

    Agilis HisPro Steerable Catheter With Electrodes

    K Number: K200721 · Decision Jun 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    Agilis HisPro Steerable Catheter With Electrodes
    K Number
    K200721
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott (St. Jude Medical)
    Date Received
    March 19, 2020
    Decision Date
    June 3, 2020
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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