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

    FRIMAP ADAPTER CONNECTOR (MAC)

    K Number: K142182 · Decision Sep 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    33
    Applicant Total
    7
    Review Days
    32

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    Basic Information

    Device Name
    FRIMAP ADAPTER CONNECTOR (MAC)
    K Number
    K142182
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topera, Inc.
    Date Received
    August 8, 2014
    Decision Date
    September 9, 2014
    Product Code
    MTD
    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
    MTD Catheter, Intracardiac Mapping, High-Density Array

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    Other Clearances by Topera, Inc.

    K Number Device Name
    K151245 Rhythm View Workstation (non-streaming, steaming option)
    K142901 RhythmView Workstation
    K133305 RHYTHM VIEW WORKSTATION
    K130827 FIRMAP CATHETER
    K123295 RHYTHM VIEW
    K110878 RHYTHMVIEW (TM)