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

    ENDOCATH ELECTROPHYSIOLOGY CATHETER

    K Number: K926549 · Decision Dec 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    7
    Review Days
    340

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    Basic Information

    Device Name
    ENDOCATH ELECTROPHYSIOLOGY CATHETER
    K Number
    K926549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endo-Therapeutics, Inc.
    Date Received
    December 31, 1992
    Decision Date
    December 6, 1993
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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