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

    DIAGNOSTIC EP CATHETER

    K Number: K915563 · Decision Mar 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    DIAGNOSTIC EP CATHETER
    K Number
    K915563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Arrhythmia Technologies, Inc.
    Date Received
    December 12, 1991
    Decision Date
    March 9, 1992
    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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    Other Clearances by Arrhythmia Technologies, Inc.

    K Number Device Name
    K915640 VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER