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

    Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

    K Number: K161464 · Decision Sep 30, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    68
    Applicant Total
    2
    Review Days
    127

    Basic Information

    Device Name
    Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
    K Number
    K161464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovative Health, LLC
    Date Received
    May 26, 2016
    Decision Date
    September 30, 2016
    Product Code
    NLH
    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
    NLH Catheter, Recording, Electrode, Reprocessed

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