BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    RITHM ID ELECTROPHYSIOLOGY CATHETER

    K Number: K133028 · Decision Mar 4, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    3
    Review Days
    159

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    Basic Information

    Device Name
    RITHM ID ELECTROPHYSIOLOGY CATHETER
    K Number
    K133028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synaptic Medical Limited
    Date Received
    September 26, 2013
    Decision Date
    March 4, 2014
    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 Synaptic Medical Limited

    K Number Device Name
    K151936 Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
    K132943 INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE